MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER COUDE TIP

Catalog Number 0168L16

Device Problems Break (1069); Fluid/Blood Leak (1250); Inflation Problem (1310); Leak/Splash (1354); Dent in Material (2526)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the 16f coude catheter was leaking from the connection site and the balloon inflation port when placed in surgery and there was not visible trauma to the catheter.The catheter was removed and another catheter was placed in which urine was noted in tubing and catheter was inserted to y-junction.When attempted to inflate the balloon, the inflation port part of the tubing expanded and always the balloon port tubing only inflated.The user removed the catheter and used individual coude cath for placement without issue.Also reportedly, the urine specimen collection port broke off when collecting catheter for infection control.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the 16f coude catheter was leaking from the connection site and the balloon inflation port when placed in surgery and there was not visible trauma to the catheter.The catheter was removed and another catheter was placed in which urine was noted in tubing and catheter was inserted to y-junction.When attempted to inflate the balloon, the inflation port part of the tubing expanded and always the balloon port tubing only inflated.The user removed the catheter and used individual coude cath for placement without issue.Also reportedly, the urine specimen collection port broke off when collecting catheter for infection control.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "user applies excessive tension".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the latex foley catheter product ifus were found to be adequate based on past reviews.Corrections: d9, h3.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the 16f coude catheter was leaking from the connection site and the balloon inflation port when placed in surgery and there was not visible trauma to the catheter.The catheter was removed and another catheter was placed in which urine was noted in tubing and catheter was inserted to y-junction.When attempted to inflate the balloon, the inflation port part of the tubing expanded and always the balloon port tubing only inflated.The user removed the catheter and used individual coude cath for placement without issue.Also reportedly, the urine specimen collection port broke off when collecting catheter for infection control.

Manufacturer Narrative

The reported event is confirmed.An amber 2 way foley catheter was returned opened without original packaging.The catheter balloon was attempted to be inflated with 10ccs of di water using a luer lock syringe.The balloon inflated to a 70:30 ratio which does not meet specification.No leaks were noted.The balloon was then deflated using a luer lock syringe without issue.Asymmetric balloon is the cause of the leak.A potential root cause for this failure could be "operator error.Dull cutting tools".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event is manufacturing related.Corrections: h3, h6.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the 16f coude catheter was leaking from the connection site and the balloon inflation port when placed in surgery and there was not visible trauma to the catheter.The catheter was removed and another catheter was placed in which urine was noted in tubing and catheter was inserted to y-junction.When attempted to inflate the balloon, the inflation port part of the tubing expanded and always the balloon port tubing only inflated.The user removed the catheter and used individual coude cath for placement without issue.Also reportedly, the urine specimen collection port broke off when collecting catheter for infection control.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER COUDE TIP
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10615076
• MDR Text Key: 209783736
• Report Number: 1018233-2020-06280
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0168L16
• Device Lot Number: NGET1029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 03/16/2021; 06/08/2021; 10/05/2021
• Supplement Dates FDA Received: 04/05/2021; 06/30/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1