MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER

Catalog Number 1853SI22

Device Problems Difficult to Insert (1316); Material Too Rigid or Stiff (1544)

Patient Problem Perforation (2001)

Event Date 05/18/2022

Event Type  Injury  

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 perforation of urethra was observed during the 3-way hydrogel coated catheter after transurethral resection of the prostate (tur-p).Urologist had difficulty getting the catheter in and got no urine in return.Cystoscopy was performed to assess damage to the urethra.More instagel was given and new tiemann pets catheter was used.In transurethral resection of the prostate (tur-p) operations, a hydrogel coated hematuria catheter had previously been used.This had now been discontinued and replaced by a new hydrogel coated prostate catheter.According to the operating urologist, the replacement product was much harder in the tip and less compliant, which they believed had caused the perforation.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "latex modulus too high".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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 perforation of urethra was observed during the 3-way hydrogel coated catheter after transurethral resection of the prostate (tur-p).Urologist had difficulty getting the catheter in and got no urine in return.Cystoscopy was performed to assess damage to the urethra.More instagel was given and new tiemann pets catheter was used.In transurethral resection of the prostate (tur-p) operations, a hydrogel coated hematuria catheter had previously been used.This had now been discontinued and replaced by a new hydrogel coated prostate catheter.According to the operating urologist, the replacement product was much harder in the tip and less compliant, which they believed had caused the perforation.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14594701
• MDR Text Key: 293286405
• Report Number: 1018233-2022-04374
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1853SI22
• Device Lot Number: MYFS2584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention