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

Catalog Number 1758SI16

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

It was reported that foley catheter placement.16f silicone foley inserted per order by jacquelyn register nurse and tara lpn.Only about 40ml return received per nursing note.Patient later urinated but mostly around the catheter.No hematuria or visible clots.Doctor on call ordered foley exchange.New 16f foley inserted by sarah register nurse and rongli register nurse.40ml yellow urine return received.Patient later urinated but mostly around the catheter.Foley was irrigated by charge register nurse and resource register nurse, but urine continued to flow around the catheter.Again, no hematuria, clots or large sediment was returned.At this point they were unable to determine the cause of the malfunction.Foley was removed and assessed by resource register nurse.Upon testing the balloon of the 16f foley that was removed, it was evident that the foley balloon was only inflating on one side of the catheter.Charge register nurse pulled another 16f from our par room and tested the balloon.Again, only one side of the catheter balloon inflated.An 18f was then tested and the balloon inflated as normal.18f foley was placed and urine was now free flowing through the catheter without leakage.

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 foley catheter placement.16f silicone foley inserted per order by (b)(6)register nurse and (b)(6)lpn.Only about 40ml return received per nursing note.Patient later urinated but mostly around the catheter.No hematuria or visible clots.Doctor on call ordered foley exchange.New 16f foley inserted by sarah register nurse and rongli register nurse.40ml yellow urine return received.Patient later urinated but mostly around the catheter.Foley was irrigated by charge register nurse and resource register nurse, but urine continued to flow around the catheter.Again, no hematuria, clots or large sediment was returned.At this point they were unable to determine the cause of the malfunction.Foley was removed and assessed by resource register nurse.Upon testing the balloon of the 16f foley that was removed, it was evident that the foley balloon was only inflating on one side of the catheter.Charge register nurse pulled another 16f from our par room and tested the balloon.Again, only one side of the catheter balloon inflated.An 18f was then tested and the balloon inflated as normal.18f foley was placed and urine was now free flowing through the catheter without leakage.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used drainage bag with inlet tube, sample port connector, catheter and test.Visual inspection of the sample noted inflated the balloon with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and no leaks observed.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed a labeling review is not required.Correction: d.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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE 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: 17964777
• MDR Text Key: 326028599
• Report Number: 1018233-2023-07583
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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: 1758SI16
• Device Lot Number: NGHR0512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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