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

Catalog Number 175812

Device Problems Burst Container or Vessel (1074); Device Slipped (1584); Material Split, Cut or Torn (4008)

Patient Problems Abdominal Pain (1685); No Consequences Or Impact To Patient (2199)

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 when the patient was going to bed, they had stomach pain and then the catheter fell out.The catheter was inspected, it was noted that the balloon had burst and there was a split in the catheter that could be realigned with no issues.There were no missing pieces noted.An additional member of the staff inspected the balloon and agreed with the previous assessment.A new catheter with a different lot number reinserted.

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿balloon collapses¿ with a potential root cause of " inflation / drainage lumen wall perforated".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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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 when the patient was going to bed, they had stomach pain and then the catheter fell out.The catheter was inspected, it was noted that the balloon had burst and there was a split in the catheter that could be realigned with no issues.There were no missing pieces noted.An additional member of the staff inspected the balloon and agreed with the previous assessment.A new catheter with a different lot number was reinserted.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9863562
• MDR Text Key: 186410604
• Report Number: 1018233-2020-01996
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 175812
• Device Lot Number: MYCRE139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1