Bard® Tiemann Model Urological Catheter Coude Tip 010114Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00801741029868), received between Jul 14, 2017 and Mar 30, 2026 — classified as 7 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (23 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Incomplete or Missing Packaging; Material Twisted/Bent

  IT WAS REPORTED THAT BARD 010114 MAY HAVE TRANSITIONED TO BD BRANDING. WITH BD BRANDED CATHETERS, THE ITEM CODE WAS STAMPED ON THE FOLEY CATHETER ITSELF BUT WAS DIFFICULT TO READ, WHEREAS THE CODE HAD BEEN EASIER TO READ WHEN THE PRODUCT WAS BARD BRANDED. ADDITIONALLY, THE DRAINAGE EYE APPEARED SMALLER. THE PRODUCT WAS ORDERED THROUGH BYRAM HEALTHCARE, AND IT WAS STATED THAT THEY ADD THE 10 BOXES OF 12 INTO ONE BOX SO THERE ARE 120 THAT SEEM TO GET TANGLED. THE TRANSITION FROM BARD TO BD AND CHANGES IN MANUFACTURING LOCATIONS WERE DISCUSSED. THE CUSTOMER WAS NOT UPSET BUT WISHED TO REPORT THE CONCERN IN CASE IT REPRESENTED A QUALITY ISSUE. CONTACTING BYRAM HEALTHCARE TO DETERMINE WHETHER THE PRODUCT COULD BE ORDERED DIFFERENTLY TO PREVENT TANGLING WAS DISCUSSED. THE MATTER WAS FORWARDED TO THE COMPLAINTS DEPARTMENT FOR APPROPRIATE HANDLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713488 ↗
• MalfunctionMar 30, 2026Incorrect Measurement

  IT WAS REPORTED THAT BARD 010114 MAY HAVE TRANSITIONED TO BD BRANDING. WITH BD BRANDED CATHETERS, THE ITEM CODE WAS STAMPED ON THE FOLEY CATHETER ITSELF BUT WAS DIFFICULT TO READ, WHEREAS THE CODE HAD BEEN EASIER TO READ WHEN THE PRODUCT WAS BARD BRANDED. ADDITIONALLY, THE DRAINAGE EYE APPEARED SMALLER. THE PRODUCT WAS ORDERED THROUGH BYRAM HEALTHCARE, AND IT WAS STATED THAT THEY ADD THE 10 BOXES OF 12 INTO ONE BOX SO THERE ARE 120 THAT SEEM TO GET TANGLED. THE TRANSITION FROM BARD TO BD AND CHANGES IN MANUFACTURING LOCATIONS WERE DISCUSSED. THE CUSTOMER WAS NOT UPSET BUT WISHED TO REPORT THE CONCERN IN CASE IT REPRESENTED A QUALITY ISSUE. CONTACTING BYRAM HEALTHCARE TO DETERMINE WHETHER THE PRODUCT COULD BE ORDERED DIFFERENTLY TO PREVENT TANGLING WAS DISCUSSED. THE MATTER WAS FORWARDED TO THE COMPLAINTS DEPARTMENT FOR APPROPRIATE HANDLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713448 ↗
• MalfunctionFeb 18, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE INSIDE OF THE INTERMITTENT CATHETERS HAD APPEARED DIRTY, ALONG WITH THE COUDE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377161 ↗
• MalfunctionDec 3, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER WAS GETTING BARD BRANDED COUDE CATHETERS BUT HAVE BEEN GETTING BD BRANDED CATHETER AND THEY HAVE A LARGER TUBING SIZE AND ALSO SOME HAVE GOTTEN CATHETER THAT HAD TWO OPENINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708803 ↗
• MalfunctionDec 3, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER WAS GETTING BARD BRANDED COUDE CATHETERS BUT HAVE BEEN GETTING BD BRANDED CATHETER AND THEY HAVE A LARGER TUBING SIZE AND ALSO SOME HAVE GOTTEN CATHETER THAT HAD TWO OPENINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708783 ↗
• MalfunctionSep 25, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PATIENT RECEIVED 2 OUT OF THE 30 CATHETERS THAT HAD BLACK MOLD LOOKING SPECS ON THE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145250 ↗
• MalfunctionSep 16, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PT SAID THAT THE TOP OF TUBE HOLE AND COUDE TIP NOT ALIGNED ON 7 CATHS, PT NOT USING BECAUSE FEAR OF PRODUCT FAILURE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064979 ↗
• MalfunctionApr 2, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE CATHETERS ARE TOO FLIMSY AND THE COUDE TIP IS TOO SMALL. PATIENT SAID IT BUCKLES SEVERELY, AND HE CANNOT INSERT THE CATHETER PROPERLY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751865 ↗
• MalfunctionApr 1, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE CATHETERS ARE TOO FLIMSY AND THE COUDE TIP IS TOO SMALL. PATIENT SAID IT BUCKLES SEVERELY, AND THEY CANNOT INSERT THE CATHETER PROPERLY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740202 ↗
• MalfunctionJan 8, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT CUSTOMER WAS STILL TRYING TO GET PICTURES OF THE URETERAL CATHETERS THAT THE THINK ACCURATELY DEMONSTRATES THE VARIATION. IT WAS MUCH MORE NOTICEABLE IN PERSON. PER SAMPLE FORM RECEIVED ON 20DEC2024, IT WAS REPORTED THAT THE PATIENT WAS GETTING THE 802514 CATHETERS THAT WERE GREAT PRODUCT NO COMPLAINTS. BUT THEN PATIENT WAS STARTED GETTING A DIFFERENT CATHETER WITH A MUCH THINNER AND POINTER, SHARPER TIP THAT WAS MADE IN MALAYSIA. IT WAS MADE FROM DIFFERENT RUBBER AND POOR QUALITY. THIS ONE USED THE SAME NUMBERS AS THE GOOD ONES, BUT SEEMED LIKE KNOCK OFF COUNTER IT. BUT THE MAIN PROBLEM WAS THE MALAYSIA ONE WAS POINTY. THE BAD ONES WERE THE MALAYSIA ONES WITH 010114 BEING THE WORST AND ALSO INCLUDED A GOOD ONE FOR COMPARISON WHICH WAS MEXICO. PATIENT EXPERIENCED DISCOMFORT AND MILD PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101135 ↗
• MalfunctionSep 26, 2024Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE PATIENT USED BARD RED RUBBER CATHETER 010114, SHIPPED TO THEM FROM THE VA MEDICAL CENTER IN A 90-DAY SUPPLY. THEY STATED THAT THEIR RECENT SHIPMENT OF CATHETERS WERE DIFFERENT THAN THE PREVIOUS SHIPMENT. LOT# MGJR3584 HAD A DIFFERENT COLOR TO THEM, MORE ORANGISH; THEY WERE FIRMER AND MORE BULBUS AT THE TIP CAUSING DISCOMFORT WHEN USED. ALSO STATED THAT THIS LOT ALSO HAD A DIFFERENT STAMP ON THEM AND WERE MADE IN MALAYSIA. THEY STATED THAT THE PREVIOUS CATHETERS WERE SOFTER. THEY HAD ADDITIONAL LOTS NGJN2942 & NGJP1135 AS WELL. REPRESENTATIVE ADVISED BD'S MANUFACTURING PROCEDURES WERE STANDARDIZED ACROSS PLANTS AND WERE BASED UPON THE SPECIFIC PRODUCT BEING MADE. THEY PROVIDED PRODUCT NUMBERS FOR HYDROPHILIC INTERMITTENT CATHETERS (120612, 50612, AND RTU12C) TO REQUEST SAMPLES FROM THE VA.

  Patient problems: Discomfort

  MAUDE report 20310133 ↗
• MalfunctionJul 25, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE 4 OF THE BARDA COUDE INTERMITTENT CATHETER PACKAGES WERE SEALED AND HAD NOTHING IN THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824699 ↗
• MalfunctionJan 24, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THESE WERE NOT COUDE BUT CAME IN COUDE BOX. REPRESENTATIVE REPLACING THE CATHETERS. PATIENT WAS ALSO DOING CLAIM WITH BARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18573657 ↗
• MalfunctionOct 20, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT 5 OF THE INTERMITTENT CATHETER COUDE TIPS WERE STRAIGHT AND NOT CURVED. CUSTOMER HAS BEEN SETTING THOSE ASIDE AND NOT USING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975295 ↗
• MalfunctionOct 4, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT FREQUENTLY RECEIVED RED RUBBER URETHRAL CATHETERS IN WHICH THE ORIENTATION BUMP WAS OFF TO ONE SIDE. WITH ENOUGH MANIPULATION THEY COULD USUALLY MAKE IT WORK, BUT THEY THOUGHT THE BUMP SHOULD ALWAYS BE IN LINE WITH THE COUDE TIP. REPRESENTATIVE AGREED WITH PATIENT. THEY HAD NO PRODUCT OR LOT OR SAMPLES AVAILABLE, ALSO ADVISED THAT NEXT TIME IF THEY RECEIVED A SHIPMENT WITH THIS ISSUE TO HOLD ONTO THE PACKAGING AND THE PRODUCT FOR INVESTIGATION. PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT THE RED RUBBER COUDE CATHETERS WERE NOT LINING UP. THEY HAD SAMPLES. ALSO PROVIDED LOT NUMBERS NGHQ0271 AND NGGY2332.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868678 ↗
• MalfunctionSep 26, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT FREQUENTLY RECEIVED RED RUBBER URETHRAL CATHETERS IN WHICH THE ORIENTATION BUMP WAS OFF TO ONE SIDE. WITH ENOUGH MANIPULATION THEY COULD USUALLY MAKE IT WORK, BUT THEY THOUGHT THE BUMP SHOULD ALWAYS BE IN LINE WITH THE COUDE TIP. REPRESENTATIVE AGREED WITH PATIENT. THEY HAD NO PRODUCT OR LOT OR SAMPLES AVAILABLE, ALSO ADVISED THAT NEXT TIME IF THEY RECEIVED A SHIPMENT WITH THIS ISSUE TO HOLD ONTO THE PACKAGING AND THE PRODUCT FOR INVESTIGATION. PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT THE RED RUBBER COUDE CATHETERS WERE NOT LINING UP. THEY HAD SAMPLES. ALSO PROVIDED LOT NUMBERS. NGHQ0271 AND NGGY2332.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819742 ↗
• MalfunctionSep 12, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT FREQUENTLY RECEIVED RED RUBBER URETHRAL CATHETERS IN WHICH THE ORIENTATION BUMP WAS OFF TO ONE SIDE. WITH ENOUGH MANIPULATION THEY COULD USUALLY MAKE IT WORK, BUT THEY THOUGHT THE BUMP SHOULD ALWAYS BE IN LINE WITH THE COUDE TIP. REPRESENTATIVE AGREED WITH PATIENT. THEY HAD NO PRODUCT OR LOT OR SAMPLES AVAILABLE, ALSO ADVISED THAT NEXT TIME IF THEY RECEIVED A SHIPMENT WITH THIS ISSUE TO HOLD ONTO THE PACKAGING AND THE PRODUCT FOR INVESTIGATION. PER FOLLOW UP VIA PHONE ON 05SEP2023, IT WAS REPORTED THAT THE RED RUBBER COUDE CATHETERS WERE NOT LINING UP. THEY HAD SAMPLES. ALSO PROVIDED LOT NUMBERS. NGHQ0271 AND NGGY2332.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729301 ↗
• MalfunctionSep 12, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT IN RED RUBBER CATHETER USUALLY THE COUDE NOTCH WAS IN LINE WITH THE COUDECURVE, BUT SOMETIMES THEY WERE NOT IN LINE. REPRESENTATIVE INFORMED INQUIRER THERE COULD HAVE BEEN AN ERROR DURING MANUFACTURING. SUGGESTED PATIENT HOLD ONTO AN EXAMPLE TO SEND IN FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729258 ↗
• MalfunctionJun 22, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE BENT AND TWISTED MAKING THEM HARD TO INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181270 ↗
• MalfunctionDec 8, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE DIRTY WHEN THEY OPENED THE INDIVIDUAL PACKAGES AND HAD A CLOUDY FILM ON OUTSIDE AND WERE VERY OILY TOWARDS THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939712 ↗
• MalfunctionDec 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THESE BARDAM COUDE CATHETER EYELETS WERE NEVER THE SAME AND THE PATIENT HAD GONE THROUGH 2 OR 3 TO GET THAT WORK PROPERLY. PATIENT ALSO STATED THAT THE MARK ON THE FUNNEL FOR THE COUDE TIP NEVER LINES UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924286 ↗
• MalfunctionDec 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THESE BARDAM COUDE CATHETER EYELETS ARE NEVER THE SAME AND THE PATIENT HAD GONE THROUGH 2 OR 3 TO GET THAT WORKS PROPERLY AND ALSO STATED THAT THE MARK ON THE FUNNEL FOR THE COUDE TIP NEVER LINES UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924283 ↗
• MalfunctionOct 18, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER RECEIVED THE INTERMITTENT CATHETERS WERE TWISTED AND UNLEVEL. STATED THAT THE CUSTOMER SUSPECT THE ISSUE OCCURRED DURING PACKAGING. PER ADDITIONAL INFORMATION RECEIVED VIA FORM WITH SAMPLE RETURNED ON 05JUL2022, CUSTOMER STATED THAT CATHETERS WERE IN INDIVIDUAL PACKAGING, ALL TWISTED. ALSO STATED THAT FOR (B)(6)PER CATHETER, THEY WOULD THINK THAT THEY COULD GET ONE THAT WAS NOT SO TWISTED. CUSTOMER THOUGHT CATHETER WERE TWISTED WHEN THE WORKERS WERE JAMMING THEM INTO PACKAGES AND POOR-QUALITY CONTROL. PER NOTIFICATION FROM INVESTIGATOR ON 07OCT2022, DURING SAMPLE EVALUATION, IT WAS FOUND THAT THE COUDE TIP AND INDICATOR NOTCH WERE FOUND TO BE MISALIGNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624518 ↗
• MalfunctionAug 25, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE STRAIGHT TIP CATHETERS WERE CAUSING THE PATIENT TO BLEED AND THEY WAS NOT ABLE TO USE THEM. PATIENT HAD SPOKEN TO DOCTOR AND SWITCHED TO COUDE TIP. PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED. PER INVESTIGATOR NOTIFICATION RECEIVED ON (B)(6) 2022. IT WAS STATED THAT THE CUSTOMER RETURNED UROLOGICAL CATHETER COUDE TIP WITH MATERIAL NUMBER 010114 AND BATCH NUMBER NGFW1717 FOR THIS COMPLAINT. PER INVESTIGATOR NOTIFICATION ON (B)(6) 2022, IT WAS FOUND THAT EXCESSIVE FLASH WAS PRESENT WITHIN THE EYELET OF ONE CATHETER AND THE COUDE TIP DID NOT ALIGN WITH THE COUDE INDICATOR ON ONE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293396 ↗
• MalfunctionJul 19, 2022Nonstandard Device; Material Twisted/Bent; Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT IN A BOX OF 12 INTERMITTENT CATHETERS ONLY 1 WORKED AND HAD DAMAGED THE PATIENT'S URETHRA WHICH STRIPPED OUT SOME OF THE MEAT SOMETIMES . PATIENT STATED THAT IN EVERY BOX THEY GOT THEY ONLY GOT 3-4 PER BOX AND WANTED TO LOOK INTO THE SIZE OF THE TUBE THAT THE CURVE AT THE END WAS WAY TOO BIG . PATIENT TRIED TO STRAIGHTEN OUT BUT SAID THAT MADE THEM ROUGH AND MADE THEM USELESS. WHEN THE PATIENT HAD THE BEND, IT PROTECTED THE INTAKE FROM SCRAPING THE URETHRA, A LOT OF THEM WERE ROUGH AND SOMETIMES THE INTAKE HOLE WAS ON THE OPPOSITE SIDE OF THE CURVE . STATED THAT SOME CATHETERS WERE FLAT AND SOME OF THEM WERE WAY TOO BIG. CUSTOMER HAD CUT TRYING TO FIGURE IT OUT. ALSO THE RUBBER OR WHATEVER MATERIAL THE CATHETERS WERE MADE OF WERE ROUGH AND HAD BUMPS. GUESSED THAT THERE ARE BUMPS ON THE INSIDE AS WELL. PATIENT STATED THAT SOME OF THE CATHETERS HAVE JAGGED HOLES AND SOME DID NOT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055320 ↗