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

Model Number 165814

Device Problems Deflation Problem (1149); Material Puncture/Hole (1504); Device Slipped (1584)

Patient Problems Urinary Retention (2119); No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2019

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 on january 16, the patient had the catheter inserted suprapubically in the angio suite.After the patient returned to their unit, it was noticed that the catheter was not draining.Staff went to irrigate the catheter and found that it had fallen out.The balloon was tested and an alleged hole was found on the balloon.They were unable to reinsert the catheter, therefore a foley had to be inserted via the patient's urethra to help relieve some pressure from retention.The patient had to return to the angio suite to have the suprapubic catheter reinserted.

Manufacturer Narrative

The device was not returned for evaluation.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: ¿to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that on january 16, the patient had the catheter inserted suprapubically in the angio suite.After the patient returned to their unit, it was noticed that the catheter was not draining.Staff went to irrigate the catheter and found that it had fallen out.The balloon was tested and an alleged hole was found on the balloon.They were unable to reinsert the catheter, therefore a foley had to be inserted via the patients urethra to help relieve some pressure from retention.The patient had to return to the angio suite to have the suprapubic catheter reinserted.

• Brand Name: BARDEX® 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: 8359771
• MDR Text Key: 139259362
• Report Number: 1018233-2019-00959
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 00801741029745
• UDI-Public: (01)00801741029745
• Combination Product (y/n): N
• PMA/PMN Number: K760093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 165814
• Device Catalogue Number: 165814
• Device Lot Number: NGCT2224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1