NA OTP5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885403284748), received between Jan 12, 2022 and Jul 2, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

2 FDA recall records name this device's identifier.

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. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2646-2020 · Root cause: Under Investigation by firm · FDA record ↗

2. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2647-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Dull, Blunt; Failure to Advance

  IT WAS REPORTED THAT MULTIPLE THORA/PARA NEEDLES WERE UNABLE TO PIERCE THE SKIN WITHOUT A PRE-CUT NICK. FOLLOWING INITIAL SKIN ACCESS, THE NEEDLES ADVANCED ROUGHLY THROUGH THE TISSUE, DESCRIBED AS SIMILAR TO A CATHETER ACCORDION EFFECT OR THE CANNULA EDGE CATCHING ON TISSUE RATHER THAN ADVANCING SMOOTHLY. THERE IS NO DEVICE TO RETURN FOR EVALUATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25694587 ↗
• MalfunctionJun 18, 2025Break; Break

  DR. *** REPORTED THAT TWO LIDOCAINE BOTTLES SHATTERED ON HIM THIS WEEK. I ALSO WITNESSED ONE LIDOCAINE BOTTLE SHATTERED ON DR. **** TODAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284026 ↗
• MalfunctionJun 17, 2025Break; Break

  DR. ***REPORTED THAT TWO LIDOCAINE BOTTLES SHATTERED ON HIM THIS WEEK. I ALSO WITNESSED ONE LIDOCAINE BOTTLE SHATTERED ON DR. ****TODAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22240400 ↗
• MalfunctionAug 23, 2024Contamination; Contamination

  IT WAS REPORTED BY CUSTOMER THAT WHEN THEY OPENED THE PACK, IT WAS A BROWN SPOT ON THE INSIDE OF THE PACKAGE. VERBATIM: THE ITEM WE HAVE IS CAT. OTP5000, AND WHEN THE PACK WAS OPENED IT WAS A BROWN SPOT ON THE INSIDE OF THE PACKAGE 1. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? LOT NUMBER 0001555079 2. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? I DO HAVE THE SAMPLE OF THE PACK WE CAN SEND. THE SAMPLE IS CURRENTLY AT OUR 1900 SOUTH AVE. LOCATION. IF YOU EMAIL ME A COPY OF THE SHIPPING LABEL I CAN PACK IT AND SEND IT TO WHERE IT NEEDS TO GO. BD REP RESPONSE RECEIVED ON 16-AUG-2024 1. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? IF YES, WHAT WAS THE IMPACT TO THE PATIENT? NO 2. IS THERE A PHOTO AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? NO. THEY ARE SENDING THE PRODUCT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048044 ↗
• MalfunctionJan 31, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE CUSTOMER OPENED THE (B)(4) WHERE A SCALPEL WAS EXPOSED. A SHARP WAS EXPOSED UPON OPENING A KIT. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE CUSTOMER OPENED THE (B)(4) WHERE A SCALPEL WAS EXPOSED. A SHARP WAS EXPOSED UPON OPENING A KIT. DESCRIBE PATIENT / (HCP) / USER IMPACT - NO IMPACT. AS PER FOLLOW-UP: - WAS THE ONLY SCALPEL WAS EXPOSED? 1. YES - WAS THERE PATIENT INVOLVEMENT? 2. NO - IF YES, WHAT WAS THE IMPACT TO THE PATIENT/USER? 3. NO - WHAT WAS DONE TO RESOLVE THE ISSUE. 6. TOSSED THE TRAY BECAUSE THERE WAS CONCERN FOR STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615493 ↗
• MalfunctionJan 22, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY CONSUMER THAT CUSTOMER HAS OPENED 3 SEPARATE OTP5000 KITS WITH PRODUCT QUALITY ISSUES. THREE INSTANCES INVOLVED: 1) UNCAPPED NEEDLE 2) BOTH LIDOCAINES WERE BROKEN OFF AND EMPTY 3) MISSING THE YUEH NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER HAS OPENED 3 SEPERATE OTP5000 KITS WITH PRODUCT QUALITY ISSUES. THREE INSTANCES INVOLVED: 1) UNCAPPED NEEDLE 2) BOTH LIDOCAINES WERE BROKEN OFF AND EMPTY 3) MISSING THE YUEH NEEDLE. HAD TO THROW 3 TRAYS BECAUSE OF STERILITY CONCERNS. HCP HAD TO OPEN A NEW TRAY, 3 TIMES. NO IMPACT TO THE PATIENT. AS PER CUSTOMER FOLLOW-UP 01/23/2023 - WAS ALL THREE-ISSUE REPORTED IS ASSOCIATED WITH THE BATCH NUMBER# 0001484674? - NO IF NOT PLEASE PROVIDE LOT NUMBERS ASSOCIATED WITH SPECIFIC FAILURE. - NO LONGER AVAILABLE WAS THERE A PATIENT INVOLVEMENT? - NO. WHAT WAS THE IMPACT TO THE PATIENT? NO. REGARDING UNCAPPED NEEDLE ISSUE - WAS THE NEEDLE PROTECTOR DETHATCHED WITHIN THE PACKAGING? YES. WAS THE NEEDLE PROTECTOR MISSING FROM THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553354 ↗
• MalfunctionJul 26, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY CUSTOMER THAT HOLE FOUND IN STERILE PACKAGE AFTER OPENING THE PACKAGE. VERBATIM: IT WAS REPORTED, WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE CONTACT THE CUSTOMER AND CC (B)(6) ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO. ITEM: OTP5000. QUANTITY AFFECTED: 1 EA . SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: HOLE FOUND IN STERILE PACKAGE AFTER OPENING THE PACKAGE. ORIGINAL PACKAGE OBTAINED WITH NO ITEM IN THE PACKAGE. THERE WAS THE ONLY ONE ISSUE OF A HOLE IN THE BAG THAT WAS SUPPOSED TO BE STERILE . I WAS JUST STATING THAT I HAD THE ORIGINAL PACKAGE BUT I DID NOT HAVE THE PRODUCT THAT WAS IN THE PACKAGE FROM THE DEPARTMENT THAT WAS REPORTING. THAT THE ITEM HAD A HOLE IN IT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397633 ↗
• InjuryMar 21, 2023Break; Break

  A CAREFUSION CATHETER FROM A THORA-PARA 5 FR NON-VALVED CATHETER DRAINAGE TRAY FELL APART DURING A PROCEDURE TODAY. THE PATIENT WAS AFFECTED. LOT #0001485831. ADDITIONAL INFORMATION RECEIVED 14-MAR-2023 ¿ PLEASE CONFIRM THE MATERIAL NUMBER. OTP5000 ¿ CAN YOU DESCRIBE AND PROVIDE MORE INFORMATION ON HOW THE TRAY FELL APART? CATHETER FELL APART ¿ INTRODUCER NEEDLE DISASSEMBLED FROM VENT PLUG ¿ HOW WAS THE PATIENT IMPACTED? HUB SEPARATION FROM CATHETER CAUSED CHEST TO BE EXPOSED TO AIR CAUSING SMALL PNEUMOTHORAX ¿ WAS THERE ANY NEED FOR MEDICAL TREATMENT OR INTERVENTION? SYRINGE WAS USED TO ASPIRATE AIR, POSTPROCEDURAL CHEST X-RAY PERFORMED NOTING SMALL HYDROPNEUMOTHORAX. NEXT DAY FOLLOW-UP. NO FURTHER ACTION REQUIRED. ¿ ARE THERE ANY PATIENT IDENTIFIERS? NOT ON THE PRODUCT, ABLE TO PROVIDE IF NECESSARY. ¿ DO YOU HAVE THE PRODUCT TO SEND BACK FOR EVALUATION? YES 14-MAR-2023 ¿ PLEASE CONFIRM THE MATERIAL NUMBER. OTP5000 ¿ CAN YOU DESCRIBE AND PROIVDE MORE INFORMATION ON HOW THE TRAY FELL APART? CATHETER FELL APART ¿ INTRODUCER NEEDLE DISASSEMBLED FROM VENT PLUG ¿ HOW WAS THE PATIENT IMPACTED? HUB SEPARATION FROM CATHETER CAUSED CHEST TO BE EXPOSED TO AIR CAUSING SMALL PNEUMOTHORAX ¿ WA

  Patient problems: Pneumothorax

  MAUDE report 16587886 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE LEAD BROKE OFF IN THE PATIENT. LEAD BROKE OFF INSIDE THE PATIENT ON (B)(6) 2022. PLEASE FOLLOW UP WITH (B)(6) FOR BATCH NUMBER, SAMPLE AVAILABILITY AND ANY ADDITIONAL INFORMATION. ON (B)(6) 2022, PLEASE PROVIDE THE FULL NAME AND ADDRESS OF THE FACILITY FOR WHERE THE ISSUE OCCURRED. (B)(6). CAN YOU PROVIDE THE LOT#? NO. WAS THERE ANY PATIENT IMPACT? WAS THERE ANY NEED FOR MEDICAL INTERVENTION? WERE THERE ANY X RAYS TAKEN? NO IMPACT, THE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ISSUES. STAFF WAS ABLE TO GRAB THE SMALL SECTION OUTSIDE THE BODY AND REMOVE WITH HEMOSTATS. WAS THE PRODUCT RETRIEVED FROM THE PATIENT? YES. DO YOU HAVE ANY PHOTOS OF THE REPORTED ISSUE? NO. IS THE PRODUCT AVAILABLE FOR EVALUATION? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537113 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT TRAY WAS BEING USED ON A PATIENT AND IT BROKE. VERBATIM: ITEM OTP5000 WAS BEING USED ON A PATIENT AND IT BROKE. IN THE PICTURE ATTACHED, I WAS TOLD THAT THE BLUE PART BROKE OFF FROM THE WHITE PART. THERE WAS NO PATIENT HARM, BUT I WANTED TO REPORT THIS FOR QUALITY CONTROL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254380 ↗
• MalfunctionMay 26, 2022Break; Break

  IT WAS REPORTED THAT CATHETERS ARE DEFECTIVE. VERBATIM: HERE ARE THE DETAILS AROUND THE OTP5000 PRODUCT I RETRIEVED FROM BOTH CAMPUSES: 8 EACH - JOHN MUIR CONCORD CAMPUS, LOT# 0001441008. 2 EACH - JOHN MUIR CONCORD CAMPUS, LOT# 0001437013. PER SALES REP NOT ALL PRODUCTS BROKE DURING USE. PRODUCTS WERE DEFECTIVE PRIOR TO USE, HOWEVER SALES REP WAS UNABLE TO GIVE SPECIFICS. ATTACHED IS THE VIDEO SENT TO ME FROM A PHYSICIAN WHO WENT TO USE THE OTP5000 THORACENTESIS CATHETER. AS YOU CAN SEE HE IS ABLE TO DISCONNECT THE BLUE CATHETER FROM THE HUB QUITE EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516709 ↗
• InjuryMay 12, 2022Break; Break

  IT WAS REPORTED BY CUSTOMER THAT PIECE BROKE APART. EMAIL VERBATIM: HERE ARE THE PICTURES OF THE PRODUCT INFORMATION AND THE PIECE THAT BROKE APART. WAS THE CATHETER BROKE DURING THE PROCEDURE OR BEFORE THE PROCEDURE? THE TUBE BROKE AWAY FROM THE HUB WHEN IT WAS BEING REMOVED FROM THE PATIENT¿S CHEST. NO DEFECT WAS NOTICED PRIOR TO USE. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? WHAT WAS THE IMPACT TO THE PATIENT? HOW WAS THE ISSUE RESOLVED? (B)(6) 2022: THE PATIENT HAD A SMALL PNEUMOTHORAX. IT DID RESOLVE AND WE DID NOT HAVE TO PUT A CHEST TUBE IN.

  Patient problems: Pneumothorax

  MAUDE report 14373353 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT CATHETER BROKE WHEN USING ON PATIENT. THERE WAS A RETAINED YEUH CATHETER REPORTED DURING A BEDSIDE PARACENTESIS PROCEDURE. STOREROOM, PURCHASING AND RISK MANAGEMENT WERE NOTIFIED. THE AFFECTED SUPPLY WAS RETRIEVED CROSS CAMPUS FROM THE PYXIS AND STOREROOM STOCK LOCATIONS. THE FDA AND MANUFACTURER WERE ALERTED TO THE EVENT AS WELL. UNFORTUNATELY, A KIT WITH THE SAME LOT# WAS STORED ON A UNIT¿S PULMONARY CART AND USED ON A DIFFERENT PATIENT. THIS RESULTED IN A NEAR MISS EVENT IN WHICH THE YEUH CATHETER BROKE AND HAD THE POTENTIAL FOR RETENTION. FORTUNATELY, THERE WAS NO HARM TO THE PATIENT DURING THIS SECOND EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236215 ↗