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

Catalog Number 175816

Device Problem Inaccurate Flow Rate (1249)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/08/2021

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 silicone foley catheter did not drain properly.Per follow up response received on (b)(6) 2021, the surgery was delayed for the patient as the user had to take the catheter out and put another one in.The user had to stop the surgery and went under to place another which probably was not the most aseptic technique.The user was unsure if the baby was comprised by mother not getting to complete due to a full bladder.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 silicone foley catheter did not drain properly.Per follow up response received on 15jan2021, the surgery was delayed for the patient as the user had to take the catheter out and put another one in.The user had to stop the surgery and went under to place another which probably was not the most aseptic technique.The user was unsure if the baby was comprised by mother not getting to complete due to a full bladder.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The drainage lumen was flushed with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and solution could be seen temporarily sitting in the funnel before dripping into the rest of the drainage lumen.The solution dripped enough to build air pockets in the lumen while draining.The reported failure was considered out of specification as the reported failure was able to be reproduced.A potential root cause for this failure could be inadequate material selection.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 luer slip tip 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." 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the silicone foley catheter did not drain properly.Per follow up response received on 15jan2021, the surgery was delayed for the patient as the user had to take the catheter out and put another one in.The user had to stop the surgery and went under to place another which probably was not the most aseptic technique.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11263593
• MDR Text Key: 229810125
• Report Number: 1018233-2021-00218
• 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: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

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 Catalogue Number: 175816
• Device Lot Number: NGES1520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/01/2021; 06/15/2021
• Supplement Dates FDA Received: 02/24/2021; 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other