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

Catalog Number 1758SI20

Device Problem Deflation Problem (1149)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 02/19/2019

Event Type  Injury  

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 foley catheter balloon could not be deflated by connecting the syringe to the valve after the catheter was inserted.The inflation funnel was cut and a guidewire was inserted into the inflation lumen, however the balloon still would not deflate.Finally, the urethra was incised and the balloon was ruptured with a needle.It was later reported that during a prostatectomy surgery the balloon could not be deflated.The physician inserted the needle from the part of the incision made to remove the prostate and punctured the balloon.The doctor did not incise the urethra to puncture the balloon.

Manufacturer Narrative

The reported event was confirmed as manufacturing related since only the manufacturing site has access to the inflation notch.Visual evaluation of the returned sample noted one opened (without original packaging) silicone foley.It was noted the inflation arm was cut off and no inflation or deflation functional testing could be done to assess the failure.The balloon was dissected to find that the inflation notch was not perforated.Inflation notches that are not properly formed are out of specification.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: "3) when it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section "troubleshooting".

Event Description

It was reported that the foley catheter balloon could not be deflated by connecting the syringe to the valve after the catheter was inserted.The inflation funnel was cut and a guidewire was inserted into the inflation lumen, however the balloon still would not deflate.Finally, the urethra was incised and the balloon was ruptured with a needle.It was later reported that during a prostatectomy surgery the balloon could not be deflated.The physician inserted the needle from the part of the incision made to remove the prostate and punctured the balloon.The doctor did not incise the urethra to puncture the balloon.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8421427
• MDR Text Key: 138819949
• Report Number: 1018233-2019-01296
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2022
• Device Catalogue Number: 1758SI20
• Device Lot Number: NGBN3261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention