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

Model Number 165818

Device Problems Material Rupture (1546); Device Slipped (1584); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

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 balloon on the silicone foley catheter ruptured and fell out of the patient.No medical intervention was reported.Per additional information received from the complainant via email, the catheter was in place for a few minutes when the balloon burst.The balloon was reportedly inflated with saline.No pieces of the balloon were observed to be missing.Catheter 165818 is a part f tray catalog a902418.

Manufacturer Narrative

The reported event was confirmed as use related.The device was used for treatment.The device had not met specifications as it was damaged.The failure was caused by the misuse of the device.Visual evaluation of the photo sample noted one opened (no original packaging), used silicone foley.The catheter balloon had a large tear along the length of the catheter.This does not meet the specification "balloon must not be torn." the investigation indicated that the reported issue was use-related.Therefore, a device history record review was not required.The instructions for use were found adequate and state the following: "attach the water filled syringe to the inflation port" while step 14 states "inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe".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 balloon on the silicone foley catheter ruptured and fell out of the patient.No medical intervention was reported.Per additional information received from the complainant via email on (b)(6)2020, the catheter was in place for a few minutes when the balloon burst.The balloon was reportedly inflated with saline.No pieces of the balloon were observed to be missing.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10093759
• MDR Text Key: 193409779
• Report Number: 1018233-2020-03463
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029769
• UDI-Public: (01)00801741029769
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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: 11/30/2021
• Device Model Number: 165818
• Device Catalogue Number: 165818
• Device Lot Number: NGDV3085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1