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

Catalog Number 900016A

Device Problems Gel Leak (1267); Device Damaged Prior to Use (2284)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

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 povidone iodine was found on the sheets prior to use.

Event Description

It was reported that povidone iodine was found on the sheets prior to use.

Manufacturer Narrative

The reported event was confirmed as supplier related.Evaluation observed that dried iodine solution had leaked around the package.The pvi package was evaluated under the microscope and it was found that there was a void or channel at the edge of the pvi sachet causing the pvi solution to leak out.The potential root cause for this reported event could be error during the manufacturing process at supplier site.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box." 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.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9582067
• MDR Text Key: 179243326
• Report Number: 1018233-2020-00248
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2022
• Device Catalogue Number: 900016A
• Device Lot Number: MYDS6977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1