Bard® Urethral Catheter 120614Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741029967), received between Jun 6, 2017 and Jan 26, 2026 — classified as 3 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (17 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE TIP OF THE CATHETER IS SHORTER AND THE CATHETER ITSELF IS THINNER THAN NORMAL. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185749 ↗
• MalfunctionApr 2, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT CUSTOMER RECEIVED 2 ORDERS OF THEIR MONTHLY SUPPLY. BOTH WERE MARKED WITH THE CORRECT SIZE, BUT 1 BOX WAS BIGGER AND CUSTOMER STATED IT WAS NOT A 14F. IT¿S TO BIG CAUSING BLEEDING EVERY TIME WITH INSERTION AND THEY COULD NOT USE THEM. IT WAS NOTED THAT THE GIVEN LOT # WAS NGJW3614. PER CUSTOMER FOLLOW UP VIA PHONE ON 05APR2025, IT WAS REPORTED THAT CUSTOMER WANTED THE DEFECTIVE CATHETERS TO BE REPLACED.

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

  MAUDE report 21751870 ↗
• MalfunctionFeb 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER DID NOT HAD EYELETS. THAT WAS UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458773 ↗
• MalfunctionFeb 6, 2025Incorrect Measurement; Material Too Rigid or Stiff; Incorrect Measurement; Material Too Rigid or Stiff

  IT WAS REPORTED THAT LOT OF NEW INTERMITTENT CATHETERS CUSTOMER RECEIVED WAS UNSATISFACTORY. THEY WERE TOO STIFF, THE WALL DIAMETER APPEARED DIFFERENT AND WAS HAVING DIFFICULTY GETTING THE CATHETER INSERTED. THEY HAD SOME BLEEDING WHEN CATHETERIZING. THEY STATED THE CATHETER APPEARED TO BE MADE OUT OF A DIFFERENT MATERIAL, BUT THEY WERE BOTH MATERIAL#120614. OLD LOT THEY LIKED NGHZ2033, NEW LOT THEY DID NOT LIKE NGJT0067. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 21321528 ↗
• MalfunctionJan 2, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE TOUCHLESS PLUS RED RUBBER INTERMITTENT CATHETER RUBBER WAS NOW A DIFFERENT COLOR AND TEXTURE SIZE. THE TIPS WERE FLIMSY, SO THEY COLLAPSED AND GOT CLOGGED AWAY EASIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056224 ↗
• MalfunctionDec 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE ISSUE NOTICED ABOUT A MONTH AGO. CUSTOMER WAS EXPERIENCING DISCOMFORT WITH TRYING TO USE THEM AND WANTED TO MAKE US AWARE OF THE ISSUE. THERE WAS A LOT THEY RECEIVED FROM THE VA. CUSTOMER STATED THAT THERE WERE HOLES ALL OVER THE CATHETER. CUSTOMER HAD ONE TO RETURN BACK FOR EVALUATION WITH LOT# NGHQ0269. PER FOLLOW UP VIA MAIL ON 15NOV2023, CUSTOMER TOOK OUT A BOX OF CATHETER LOT NUMBER NGHV0201 TO USE AND FOUND OUT THAT IT WAS DEFECTIVE. THERE WAS A HOLE BELOW THE TIP AND DOWN THE SIDE, THIS CAUSED PAIN AND DISCOMFORT WHEN INSERTED IN THE URETHRA AND THEIR BLADDER DID NOT EMPTY. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA MAIL ON 11DEC2023, THE PLACEMENT OF THE VARIATION OF HOLES IN THE CATHETERS. I HAVE KEPT THREE BOXES OF THE CATHETERS AND RETURNED REST TO THE COMPANY. THE CATHETERS HAD TWO DIFFERENT HOLES NOWHERE NEAR THE TIP OF THE CATHETER. THE ONE ON THE LEFT SIDE, AS IT WAS BEING INSERTED, WOULD CAUSE EXTREME IRRITATION WITH LOT# NGHU0540. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18401672 ↗
• MalfunctionDec 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE ISSUE NOTICED ABOUT A MONTH AGO. CUSTOMER WAS EXPERIENCING DISCOMFORT WITH TRYING TO USE THEM AND WANTED TO MAKE US AWARE OF THE ISSUE. THERE WAS A LOT THEY RECEIVED FROM THE VA. CUSTOMER STATED THAT THERE WERE HOLES ALL OVER THE CATHETER. CUSTOMER HAD ONE TO RETURN BACK FOR EVALUATION WITH LOT# NGHQ0269. PER FOLLOW UP VIA MAIL ON 15NOV2023, CUSTOMER TOOK OUT A BOX OF CATHETER LOT NUMBER NGHV0201 TO USE AND FOUND OUT THAT IT WAS DEFECTIVE. THERE WAS A HOLE BELOW THE TIP AND DOWN THE SIDE, THIS CAUSED PAIN AND DISCOMFORT WHEN INSERTED IN THE URETHRA AND THEIR BLADDER DID NOT EMPTY. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA MAIL ON 11DEC2023, THE PLACEMENT OF THE VARIATION OF HOLES IN THE CATHETERS. I HAVE KEPT THREE BOXES OF THE CATHETERS AND RETURNED REST TO THE COMPANY. THE CATHETERS HAD TWO DIFFERENT HOLES NOWHERE NEAR THE TIP OF THE CATHETER. THE ONE ON THE LEFT SIDE, AS IT WAS BEING INSERTED, WOULD CAUSE EXTREME IRRITATION WITH LOT# NGHU0540. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400427 ↗
• MalfunctionDec 6, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE ISSUE NOTICED ABOUT A MONTH AGO. CUSTOMER WAS EXPERIENCING DISCOMFORT WITH TRYING TO USE THEM AND WANTED TO MAKE US AWARE OF THE ISSUE. THERE WAS A LOT THEY RECEIVED FROM THE VA. CUSTOMER STATED THAT THERE WERE HOLES ALL OVER THE CATHETER. CUSTOMER HAD ONE TO RETURN BACK FOR EVALUATION WITH LOT# NGHQ0269. PER FOLLOW UP VIA MAIL ON 15NOV2023, CUSTOMER TOOK OUT A BOX OF CATHETER LOT NUMBER NGHV0201 TO USE AND FOUND OUT THAT IT WAS DEFECTIVE. THERE WAS A HOLE BELOW THE TIP AND DOWN THE SIDE, THIS CAUSED PAIN AND DISCOMFORT WHEN INSERTED IN THE URETHRA AND THEIR BLADDER DID NOT EMPTY. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA MAIL ON 11DEC2023, THE PLACEMENT OF THE VARIATION OF HOLES IN THE CATHETERS. THEY HAVE KEPT THREE BOXES OF THE CATHETERS AND RETURNED REST TO THE COMPANY. THE CATHETERS HAD TWO DIFFERENT HOLES NOWHERE NEAR THE TIP OF THE CATHETER. THE ONE ON THE LEFT SIDE, AS IT WAS BEING INSERTED, WOULD CAUSE EXTREME IRRITATION WITH LOT# NGHU0540. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 18273992 ↗
• MalfunctionNov 22, 2023Component Misassembled; Material Split, Cut or Torn; Component Misassembled; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ISSUE NOTICED ABOUT A MONTH AGO. CUSTOMER WAS EXPERIENCING DISCOMFORT WITH TRYING TO USE THEM AND WANTED TO MAKE US AWARE OF THE ISSUE. THERE WAS A LOT THEY RECEIVED FROM THE VA. CUSTOMER STATED THAT THERE WERE HOLES ALL OVER THE CATHETER. CUSTOMER HAD ONE TO RETURN BACK FOR EVALUATION WITH LOT# NGHQ0269. PER FOLLOW UP VIA MAIL ON 15NOV2023, CUSTOMER TOOK OUT A BOX OF CATHETER LOT NUMBER NGHV0201 TO USE AND FOUND OUT THAT IT WAS DEFECTIVE. THERE WAS A HOLE BELOW THE TIP AND DOWN THE SIDE, THIS CAUSED PAIN AND DISCOMFORT WHEN INSERTED IN THE URETHRA AND THEIR BLADDER DID NOT EMPTY. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA MAIL ON 11DEC2023, THE PLACEMENT OF THE VARIATION OF HOLES IN THE CATHETERS. I HAVE KEPT THREE BOXES OF THE CATHETERS AND RETURNED REST TO THE COMPANY. THE CATHETERS HAD TWO DIFFERENT HOLES NOWHERE NEAR THE TIP OF THE CATHETER. THE ONE ON THE LEFT SIDE, AS IT WAS BEING INSERTED, WOULD CAUSE EXTREME IRRITATION WITH LOT# NGHU0540.NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18192486 ↗
• MalfunctionJul 5, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE TIEMANN CATHETER OPENED AND READY TO USE AND A WHITE POWDER WAS FOUND THROUGHOUT THE LENGTH OF THE CATHETER IN THE PACKAGING. STATED THAT THE PACKAGE OPENED PRIOR TO USE AND NOT ABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260837 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING AND INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

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

  MAUDE report 17125190 ↗
• MalfunctionApr 5, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THESE TIEMANN CATHETER WERE TOO THICK AND WERE SCRAPING AGAINST THE PATIENT URETHRA. IT WAS STATED WHEN THE PATIENT WAS REMOVING THEM IT WAS PAINFUL AND CAUSING BLEEDING EVEN WITH LUBRICANT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 16681849 ↗
• MalfunctionMay 13, 2022Material Twisted/Bent; Component Misassembled; Material Twisted/Bent; Component Misassembled

  IT WAS REPORTED THAT THE COUPLE OF INTERMITTENT CATHETERS WERE NOT STRAIGHT, THEY WERE A S SHAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397871 ↗
• MalfunctionMar 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE COLOR OF THE INTERMITTENT CATHETER WAS LIGHT ORANGE WHEN THE PATIENT STARTED TO USE IT BUT THE CATHETER FROM THE LAST ORDER WAS MORE OF A DARKER SHADE OF ORANGE AND RED. PATIENT STATED THAT THE DARKER CATHETER'S RUBBER WAS HARDER THAN THE LIGHTER ONE AND SEEMED HARDER TO INSERT WHICH SEEMED TO CAUSE MORE IRRITATION THAN THE LIGHTER ONE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14JAN2022, THE PROBLEM WAS THAT THE DARK BROWN COLORED CATHETERS SEEMED HARDER THAN THE LIGHTER, ORANGE-COLORED ONES CAUSING MORE IRRITATION WHEN INSERTED. IT WAS ALSO STATED THAT THE DARKER COLORED ONES ALSO HAD THE DIMPLE THAT DID NOT LINE UP WITH THE CURVED END, WHICH MADE IT MORE DIFFICULT TO INSERT STRAIGHT. PER ADDITIONAL INFORMATION VIA FORM WITH SAMPLE RETURNED ON 09FEB2022, CUSTOMER HAD URINARY TRACT INFECTION USING THE INTERMITTENT CATHETERS ((B)(4)). CUSTOMER ALSO STATED THAT THE CATHETERS WERE BROWN IN COLOR AND NOT IN ORANGE OR RED ((B)(4)), AND SEEMS HARDER ((B)(4)). ON SOME CATHETER THE DIMPLES DID NOT MATCH UP WITH THE CURVE ON THE OTHER END ((B)(4)). CUSTOMER WAS CONCERNED IF THEY WERE AS STERILE AS HAVING MORE URINARY TRACT INFECTION THAN WITH THE ONES THAT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693657 ↗
• InjuryMar 8, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COLOR OF THE INTERMITTENT CATHETER WAS LIGHT ORANGE WHEN THE PATIENT STARTED TO USE IT BUT THE CATHETER FROM THE LAST ORDER WAS MORE OF A DARKER SHADE OF ORANGE AND RED. PATIENT STATED THAT THE DARKER CATHETER'S RUBBER WAS HARDER THAN THE LIGHTER ONE AND SEEMED HARDER TO INSERT WHICH SEEMED TO CAUSE MORE IRRITATION THAN THE LIGHTER ONE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14JAN2022, THE PROBLEM WAS THAT THE DARK BROWN COLORED CATHETERS SEEMED HARDER THAN THE LIGHTER, ORANGE-COLORED ONES CAUSING MORE IRRITATION WHEN INSERTED. IT WAS ALSO STATED THAT THE DARKER COLORED ONES ALSO HAD THE DIMPLE THAT DID NOT LINE UP WITH THE CURVED END, WHICH MADE IT MORE DIFFICULT TO INSERT STRAIGHT. PER ADDITIONAL INFORMATION VIA FORM WITH SAMPLE RETURNED ON (B)(6) 2022, CUSTOMER HAD URINARY TRACT INFECTION USING THE INTERMITTENT CATHETERS (NGFP3267 AND NGFR2541). CUSTOMER ALSO STATED THAT THE CATHETERS WERE BROWN IN COLOR AND NOT IN ORANGE OR RED (NGFP3267 AND NGFR2541), AND SEEMS HARDER (NGFP3267 AND NGFR2541). ON SOME CATHETER THE DIMPLES DID NOT MATCH UP WITH THE CURVE ON THE OTHER END (NGFP3267 AND NGFR2541). CUSTOMER WAS CONCERNED IF THEY WERE AS STERILE AS

  Patient problems: Urinary Tract Infection

  MAUDE report 13693468 ↗
• InjuryMar 8, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COLOR OF THE INTERMITTENT CATHETER WAS LIGHT ORANGE WHEN THE PATIENT STARTED TO USE IT BUT THE CATHETER FROM THE LAST ORDER WAS MORE OF A DARKER SHADE OF ORANGE AND RED. PATIENT STATED THAT THE DARKER CATHETER'S RUBBER WAS HARDER THAN THE LIGHTER ONE AND SEEMED HARDER TO INSERT WHICH SEEMED TO CAUSE MORE IRRITATION THAN THE LIGHTER ONE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2022, THE PROBLEM WAS THAT THE DARK BROWN COLORED CATHETERS SEEMED HARDER THAN THE LIGHTER, ORANGE-COLORED ONES CAUSING MORE IRRITATION WHEN INSERTED. IT WAS ALSO STATED THAT THE DARKER COLORED ONES ALSO HAD THE DIMPLE THAT DID NOT LINE UP WITH THE CURVED END, WHICH MADE IT MORE DIFFICULT TO INSERT STRAIGHT. PER ADDITIONAL INFORMATION VIA FORM WITH SAMPLE RETURNED ON (B)(6) 2022, CUSTOMER HAD URINARY TRACT INFECTION USING THE INTERMITTENT CATHETERS (NGFP3267 AND NGFR2541). CUSTOMER ALSO STATED THAT THE CATHETERS WERE BROWN IN COLOR AND NOT IN ORANGE OR RED (NGFP3267 AND NGFR2541), AND SEEMS HARDER (NGFP3267 AND NGFR2541). ON SOME CATHETER THE DIMPLES DID NOT MATCH UP WITH THE CURVE ON THE OTHER END (NGFP3267 AND NGFR2541). CUSTOMER WAS CONCERNED IF THEY WERE AS STERILE

  Patient problems: Urinary Tract Infection

  MAUDE report 13693196 ↗
• MalfunctionMar 8, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT FEW OF INTERMITTENT CATHETERS WAS FOUND DISCOLORED INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688516 ↗
• MalfunctionFeb 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE COLOR OF THE BARD TIEMANN MODEL COUDE TIP 14FR INTERMITTENT CATHETER WAS LIGHTER ORANGE WHEN THE CUSTOMER FIRST STARTED USING IT, BUT THE CATHETERS FROM THE LAST ORDER WAS MORE OF A DARKER SHADE OF ORANGE OR RED. IT WAS ALSO STATED THAT THE DARKER ONES SEEMED LIKE THE RUBBER WAS HARDER THAN THE LIGHTER ONE AND HARDER TO INSERT WHICH SEEMED TO CAUSE MORE IRRITATION THAN THE LIGHTER ONES. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14JAN2022, THE PROBLEM WAS THE DARK BROWN COLORED CATHETERS SEEMED HARDER THAN THE LIGHTER ORANGE COLORED ONES CAUSING MORE IRRITATION WHEN INSERTED. IT WAS ALSO STATED THAT THE DARKER COLORED ONES ALSO HAD THE DIMPLE THAT DID NOT LINE UP WITH THE CURVED END, WHICH MADE IT MORE DIFFICULT TO INSERT STRAIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467459 ↗
• MalfunctionAug 23, 2021Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS DIFFICULT TO INSERT AND BENDS. THE PATIENT CLEANS IT WITH ALCOHOL AND THEN ADDED LUBRICANT. ALSO STATED THAT THE CATHETER WAS FOUND TO BE SMALLER IN DIAMETER. THE LIBERATOR REPRESENTATIVE SUGGESTED THAT IT WAS ALREADY HYDRO AND DID NOT NEED CLEANING MORE JELLY AND ALSO SUGGESTED THAT THE PATIENT CAN TRY ANOTHER ONE WITHOUT CLEANING IT AND ADD MORE JELL IF IT DID NOT MOVE SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353278 ↗
• MalfunctionAug 16, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS DIFFICULT TO INSERT AND BENDS. THE PATIENT CLEANS IT WITH ALCOHOL AND THEN ADDED LUBE. IT WAS ALSO STATED THAT THE CATHETER WAS FOUND TO BE SMALLER IN DIAMETER. THE LIBERATOR REPRESENTATIVE SUGGESTED THAT IT WAS ALREADY HYDRO AND DID NOT NEED CLEANING MORE JELLY AND ALSO SUGGESTED THAT THE PATIENT CAN TRY ANOTHER ONE WITHOUT CLEANING IT AND ADD MORE JELL IF IT DID NOT MOVE SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328854 ↗
• MalfunctionAug 16, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS DIFFICULT TO INSERT AND BENDS. THE PATIENT CLEANS IT WITH ALCOHOL AND THEN ADDED LUBE. IT WAS ALSO STATED THAT THE CATHETER WAS FOUND TO BE SMALLER IN DIAMETER. THE LIBERATOR REPRESENTATIVE SUGGESTED THAT IT WAS ALREADY HYDRO AND DID NOT NEED CLEANING MORE JELLY AND ALSO SUGGESTED THAT THE PATIENT CAN TRY ANOTHER ONE WITHOUT CLEANING IT AND ADD MORE JELL IF IT DID NOT MOVE SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328808 ↗
• MalfunctionAug 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE WAY TIEMANN CATHETERS WERE PACKAGED ALLOWED THEM TO BECOME TWISTED, AND THE GUIDE AT THE END OF THE COUDE TIP WAS NOT POSITIONED CORRECTLY, WHICH CAUSED THE CATHETERS NOT TO BE INSERTED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307215 ↗
• MalfunctionJun 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER HAD NO EYELETS FOR URINE TO COME OUT. PER FOLLOW UP VIA PHONE ON 11MAY2021, CUSTOMER HAD ISSUES WITH THE PACKAGING. CUSTOMER RECEIVED SEVERAL BOXES WHERE 6 AND 7 CATHETERS STUCK TOGETHER IN THE PACKAGING AND SOME WHERE THEY WILL BE BENT AROUND EACH OTHER MAKING THEM DIFFICULT TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926472 ↗
• MalfunctionMay 10, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT HAD TWO TIEMANN CATHETERS WHICH WERE HAVING NO EYELETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801953 ↗
• MalfunctionMay 10, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN THE PATIENT WAS TRYING TO DRAIN THE BLADDER WITH THE CATHETER NO URINE CAME OUT. WHEN THE PATIENT REMOVED THE CATHETER IT WAS NOTED THAT THERE WERE NO EYEHOLES AT THE TIP. IT WAS NOTED THAT THE PATIENT SELECTED ANOTHER CATHETER FROM THE BOX (SAME LOT) AND WAS ABLE TO DRAIN THE BLADDER. PER FOLLOW UP VIA PHONE ON 16APR2021 THE CUSTOMER HAD AN ADDITIONAL CATHETER THAT WAS MISSING THE EYELETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801876 ↗