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

Catalog Number 175814

Device Problems Inadequate Instructions for Healthcare Professional (1319); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the customer received the item with an incorrect ifu.The customer alleged that the product was a standard length catheter and the ifu was for the female length catheter.

Manufacturer Narrative

The reported event was confirmed as design related, as the instructions for use were found inadequate.A photo sample was returned for evaluation.According to the bill of materials, product catalog number d175814e is a male catheter.The ifu was reviewed, which states the following: "female use only refer to direct unit label for product content and gender specific use where applicable".Reviewed variable print a/w ¿ cardboard sleeve label, which did not indicate any gender.The instructions-for-use (ifu) were found to be inadequate.The dhr did not detect any abnormalities.The device was distributed with intended labeling.The root cause for this failure mode was the variable print a/w ¿ cardboard sleeve label artwork and/or the ifu artwork were inadequately designed.

Event Description

It was reported that the customer received the item with an incorrect ifu.The customer alleged that the product was a standard length catheter and the ifu was for the female length catheter.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7705973
• MDR Text Key: 114805901
• Report Number: 1018233-2018-02903
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

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 Expiration Date: 11/01/2022
• Device Catalogue Number: 175814
• Device Lot Number: MYCPE867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1