Bard® Silastic® Foley Catheter 33420Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741020001), received between Apr 20, 2017 and Dec 2, 2025 — classified as 12 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 23, 2026Open, Classified

   Due to stain present on the surface of affected foley catheters.

   Z-2226-2026 · Root cause: Material/Component Contamination · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS: PATIENT# 1 - (B)(6) (40YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVERY 3 WEEKS)

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23696696 ↗
• InjuryDec 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS: PATIENT# 1 - (B)(6) (40YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVERY 3 WEEK

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23694274 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE NININGER CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT NININGER AND HASTINGS CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPPED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS, PATIENT# 1 - (B)(6) (40YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694118 ↗
• InjuryDec 2, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS: PATIENT# 1 - (B)(6) (40YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVERY 3 WEEKS)

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23693154 ↗
• InjuryDec 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS: PATIENT# 1 - (B)(6) (40 YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVERY 3 WEE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23693146 ↗
• InjuryDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS: PATIENT# 1 - (B)(6) (40YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVERY 3 WEEKS)

  Patient problems: Tachycardia

  MAUDE report 23693143 ↗
• InjuryDec 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE NININGER CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT NININGER AND HASTINGS CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND TREENA IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND EMERGENCY ROOM TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND EMERGENCY ROOM DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS: PATIENT# 1 - (B)(6) (40YO WHITE MALE, HT: 5¿4¿

  Patient problems: Burning Sensation

  MAUDE report 23693139 ↗
• MalfunctionDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT HASTINGS CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND THEY ARE WORKING WITH TO ENSURE THERE ARE NO OTHER IMPACTED PRODUCTS. LOT NGJZ036. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS, PATIENT 1 (CATHETER CHANGE EVERY 3 WEEKS). ON (B)(6) 2025, THE PATIENT HAD NURSE VISIT FOR R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693138 ↗
• InjuryNov 26, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) AND (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS, PATIENT# 1 - (B)(6) (40YR WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23656455 ↗
• InjuryNov 26, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS, PATIENT# 1 - (B)(6). (40YR WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVERY 3 WEEKS

  Patient problems: Pain

  MAUDE report 23656452 ↗
• InjuryNov 26, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE (B)(6) CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT (B)(6) CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND (B)(6) IS WORKING WITH (B)(6) TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS, PATIENT# 1 - (B)(6). (40YR WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHANGE EVERY 3 WEEKS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23656450 ↗
• InjuryOct 29, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THIS IS A CLINIC ONLY CATHETER THAT CAUSED 3 DIFFERENT PATIENTS AT THE NININGER CLINIC TO REQUIRE TRIPS TO THE ED DUE TO THE CATHETER NOT DRAINING, IT IS ONLY LOCATED AT NININGER AND HASTINGS CLINICS, THOSE CLINICS HAVE PULLED THE LOTS, AND TREENA IS WORKING WITH JULIE TO ENSURE NO OTHER IMPACTED PRODUCTS. LOT # NGJZ0361. PATIENT WAS BROUGHT TO EXAM ROOM AND PLACED IN SUPINE POSITION ON THE EXAM TABLE. CATHETER WAS IRRIGATED AND MINIMAL AMOUNT OF URINE SOLUTION WAS ABLE TO BE PULLED BACK, AND CATHETER WAS VERY SLOWLY DRAINING. BALLOON WAS DEFLATED AND URINE FLOW IMMEDIATELY INCREASED. CATHETER WAS ADVANCED 1.5 INCHES FURTHER INTO BLADDER AND WRITER BEGAN TO INFLATE BALLOON. IMMEDIATELY WHEN ANY FLUID WAS INSTILLED INTO BALLOON, URINE FLOW STOPS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07NOV2025, THERE WAS IMPACT TO THE PATIENT DUE TO THE THIS OF THE DEVICE. SOME CASES RESULTED IN MULTIPLE CATHETER CHANGES AND ER TRIPS WITH ALTERNATIVE CATHETER TYPES. TROUBLE SHOOTING WAS PERFORMED IN CLINIC AND ER DEPENDING ON WHERE PATIENT WAS SEEN FOR ISSUES. THE KNOWN PATIENTS AFFECTED BY THIS, PATIENT# 1 - (B)(6) (40 YO WHITE MALE, HT: 5¿4¿ WT: 67KG & CATHETER CHAN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23414312 ↗
• MalfunctionJul 17, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THEY HAD OPENED MULTIPLE CATHETERS AND THESE LOT# ARE REF# (B)(4), LOT #NGJX4260 REF# (B)(4), LOT# NGJZ0361, LOT#NGJX3010 ARE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535559 ↗
• MalfunctionJul 17, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THEY HAD OPENED MULTIPLE CATHETERS AND THESE LOT# ARE REF #33618, LOT # NGJX4260 REF #33420, LOT # NGJZ0361, LOT#NGJX3010 ARE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535555 ↗
• MalfunctionAug 27, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE REVISION OF THE FOLEY CATHETER SINCE THE PACKAGING AND THE INVOICE SAYS EXPIRATION DATE 08/31/2026 AND THE PROBE SAYS (B)(6) 2024. PER ADDITIONAL INFORMATION RECEIVED VIA IBC ON 19AUG2024, STATED THAT (B)(4) PIECES ARRIVED OF WHICH (B)(4) PIECES WERE SOLD AND CONFIRMED DATE OF THE EVENT ON (B)(6)2024 THAT WE BECAME AWARE OF. ONLY 45 PCS RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS. (B)(4) PIECES SOLD ALSO HAD THE SAME PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077741 ↗
• MalfunctionAug 6, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT THERE WAS A CORRUGATED BOX CONTAINING 10 PIECES OF SILASTIC FOLEY CATHETER PRODUCT IN THE WAREHOUSE. HOWEVER, UPON INSPECTION OF THE UNITS, IT WAS OBSERVED THAT THE EXPIRATION DATE ON THE SECONDARY PACKAGING DIFFERS SINCE IT SPECIFIED 08-31-2026, WHICH DOES NOT COINCIDE BECAUSE THE PRIMARY PACKAGING STATED THE EXPIRATION DATE 04-30-2024, I.E. IT HAS ALREADY EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917411 ↗
• MalfunctionJul 9, 2024Wrong Label; Wrong Label

  IT WAS REPORTED 20 PIECES OF SILASTIC 33420 NEEDLES, WHICH ARRIVED LAST JUNE 12. THEY WERE DELIVERED IN A CLOSED BOX, THE LOT# NGJQ1723 AND EXPIRATION DATE ON THE BOX WERE 08/31/2026 RESPECTIVELY. WHEN THEY TOOK OUT THE NEEDLES, THEY NOTICED THAT THEY HAD THE SAME LOT, BUT WITH EXPIRATION DATE WAS 04/30/2024. THE LOT CORRESPONDS BUT THEY ARE ALREADY EXPIRED. THERE WAS NO IMPACT TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 22JUL2024, CUSTOMER CONFIRMED THE PRODUCT WAS NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702763 ↗
• MalfunctionJul 8, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT ON JUNE 12 THEY RECEIVED FOLEY CATHETER (CODE 33420) IN THEIR WAREHOUSE WITH LOT NUMBER NGJQ1723, WHEN PERFORMING THE INDIVIDUAL REVIEW OF THE PRODUCT, THEY NOTICED THAT THE BOX WAS MARKED WITH EXPIRATION ON AUGUST 31, 2026, BUT IN THE PRIMARY PACKAGING APPEARED THE EXPIRATION ON APRIL 30, 2024. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689755 ↗
• MalfunctionJun 28, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT OUTSIDE BOX HAD EXPIRATION DATE OF 31AUG2026, BUT THE FOLEY CATHETERS IN THE BOX EXPIRED ON 30APR2024. IT WAS THE SAME ON BOTH BOXES. PER FOLLOW UP RESPONSE VIA EMAIL ON 14JUN2024, IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED. CUSTOMER NOTICED THIS WHEN THEY TOOK THEM OUT OF THE BOX. THEY HAD 2 BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632934 ↗
• MalfunctionJun 26, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT OUTSIDE BOX HAD EXPIRATION DATE OF 31AUG2026, BUT THE FOLEY CATHETERS IN THE BOX EXPIRED ON 30APR2024. IT WAS THE SAME ON BOTH BOXES. PER FOLLOW UP RESPONSE VIA EMAIL ON (B)(6) 2024, IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED. CUSTOMER NOTICED THIS WHEN THEY TOOK THEM OUT OF THE BOX. THEY HAD 2 BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613601 ↗
• MalfunctionApr 5, 2024Component Misassembled; Component Misassembled

  IIT WAS REPORTED THAT THE FOLEY CATHETER PROBE DESIGN WAS DEFECTIVE AS IT WAS MISSING A PLASTIC PART IN THE PART WHERE THE BALLOON WAS INFLATED, THE WASHER THAT INDICATES THE MEASUREMENT OF THE PROBE AND LOT WAS MISSING. THE CATHETER PACKAGE WAS NOT OPENED AND WAS NOT USED ON THE PATIENT. AS PER THE ADDITIONAL INFORMATION RECEIVED ON 19MAR2024, THE CUSTOMER CONFIRMED THAT THE WASHER WAS NOT BROKEN BUT IT DID NOT COME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051825 ↗
• MalfunctionApr 4, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE SILASTIC FOLEY CATHETER DID NOT HAVE COLOR BUTTON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039905 ↗
• InjuryJul 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT CUSTOMER WAS HOSPITALIZED, UNSURE OF HOW FOLEY CATHETERS FAILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17277968 ↗
• InjuryJul 5, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A FAULTY BARD FOLEY CATHETER. STATED THAT THE FOLEY CATHETER EXPLODED WHILE INSIDE PATIENT AND THE CATHETER WAS SURGICALLY REMOVED. PATIENT ALSO STATED THAT THEY DID NOT OVERFILL THE BALLOON AND WENT TO HOSPITAL IN MAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17262440 ↗
• MalfunctionNov 2, 2017Packaging Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN EMPTY CATHETER PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995965 ↗