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

Catalog Number 0165SI14

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Event Description

It was reported that the patient had been back in touch to state their new replacement order was exactly the same as d236914s-all 8" (lot# nghn4359) instead of the usual 11-and all had the same lot number as stock we had issues with last month (lot# nghn4359).It was stated that they had checked the stock on shelves and that it was all the same issue and lot number.It was also stated that they had checked the new order of 12ch d236912s they have in stock, and they were also 8" instead of the usual 11 (lot# unk)".Per additional information via email from ibc on 02aug2023, it was stated that the all of the same lot.Number so 12 catheters in total.The patient had the same issue in june with all 12 catheters being affected also.In total all 24 catheters had been the same lot number.It was also stated that the our stock of 12ch have the same issue also and not sure if the lot number was the same on those.

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 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 patient had been back in touch to state their new replacement order was exactly the same as d236914s-all 8" (lot# nghn4359) instead of the usual 11-and all had the same lot number as stock we had issues with last month (lot# nghn4359).It was stated that they had checked the stock on shelves and that it was all the same issue and lot number.It was also stated that they had checked the new order of 12ch d236912s they have in stock, and they were also 8" instead of the usual 11 (lot# unk)".Per additional information via email from ibc on 02aug2023, it was stated that the all of the same lot number so 12 catheters in total.The patient had the same issue in june with all 12 catheters being affected also.In total all 24 catheters had been the same lot number.It was also stated that the our stock of 12ch have the same issue also and not sure if the lot number was the same on those.

Manufacturer Narrative

The reported event was confirmed as design related.Potential root cause could be due to inadequate procedure guideline during product transfer.A device history record review was not required.The reported event was understood, characterized, and confirmed as unrelated to the labeling issue.Hence, a labeling review was not required.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 actual/suspected device was inspected.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17470940
• MDR Text Key: 321520080
• Report Number: 1018233-2023-05858
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165SI14
• Device Lot Number: NGHN4359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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): Other