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

Catalog Number 1758SI14

Device Problems Failure to Infuse (2340); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2023

Event Type  malfunction  

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 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 foley balloon did not inflate during the pre-test.The inflation funnel did not swell.There was no dent mark or abnormality observed on the catheter.The water was injected vigorously.Usually the balloon can be inflated within around 5 seconds.The syringe plunger was unable to push and so the balloon was difficult to inflate.Per follow up information received via ibc on 19jul2023, there was no details provided from the customer regarding if the inoperable syringe led to difficulty in inflating the balloon.

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 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 foley balloon did not inflate during the pre-test.The inflation funnel did not swell.There was no dent mark or abnormality observed on the catheter.The water was injected vigorously.Usually the balloon can be inflated within around 5 seconds.The syringe plunger was unable to push and so the balloon was difficult to inflate.Per follow up information received via ibc on 19jul2023, there was no details provided from the customer regarding if the inoperable syringe led to difficulty in inflating the balloon.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.No root cause could be found because the reported event was unconfirmed.Photo: there are 2 photos that were sent by the customer.The first photo attached is an overview of the catheter wit cut portion of inlet tubing.The second photo shows the balloon portion and the tip of the catheter at a resting state.Visual: visual evaluation of the returned sample noted one opened (without original packaging), 2-way catheter with cut portion of inlet tubing.Visual inspection noted no obvious defects.Using the in-house syringe, the catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.The balloon passively deflated in under 2 minutes with no cuffing or leaks noted, returning 10ml of solution.This is within specification which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.A device history record review was not required as the investigation was unconfirmed.As the reported event is unconfirmed neither a risk review nor labeling review is required.H11: section a through f - the information provided by bd represents all 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 foley balloon did not inflate during the pre-test.The inflation funnel did not swell.There was no dent mark or abnormality observed on the catheter.The water was injected vigorously.Usually the balloon can be inflated within around 5 seconds.The syringe plunger was unable to push and so the balloon was difficult to inflate.Per follow up information received via ibc on 19jul2023, there was no details provided from the customer regarding if the inoperable syringe led to difficulty in inflating the balloon.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17434491
• MDR Text Key: 320149454
• Report Number: 1018233-2023-05662
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K984136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1758SI14
• Device Lot Number: MYGV0716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other