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

Catalog Number 1758SI18

Device Problems Failure to Infuse (2340); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that the user felt strong tactile resistance as he/she attempted to inject water into the balloon with a syringe.Therefore, the catheter was not used.

Manufacturer Narrative

The reported issue was confirmed as manufacturer related.Per visual evaluation, no issues were observed for the problem reported.During functional evaluation the catheter balloon was inflated with air and deflated without any issues.An attempt to inflate the catheter balloon was done with a 10 cc of a mix of tap water and blue methylene, and strong resistance was felt.The device was then dissected and it was noted that the catheter was occluded with silicone at the bifurcation area inside of the inflation lumen.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "recommended inflation capacities, 3cc balloon: use 5cc sterile water, 5cc balloon: use 10cc sterile water, 30cc balloon: use 35cc sterile water, do not exceed recommended capacities." (b)(4).

Event Description

It was reported that the user felt strong tactile resistance as he/she attempted to inject water into the balloon with a syringe.Therefore, the catheter was not used.

Manufacturer Narrative

The reported issue was confirmed as manufacturer related.Per visual evaluation, no issues were observed for the problem reported.During functional evaluation the catheter balloon was inflated with air and deflated without any issues.An attempt to inflate the catheter balloon was done with a 10 cc of a mix of tap water and blue methylene, and strong resistance was felt.The device was then dissected and it was noted that the catheter was occluded with silicone at the bifurcation area inside of the inflation lumen.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities." (b)(4).

Event Description

It was reported that the user felt strong tactile resistance as he/she attempted to inject water into the balloon with a syringe.Therefore, the catheter was not used.Per additional information, the catheter was used on the patient once.Following insertion, the user attempted to inject water into the balloon using a syringe, but he/she felt a strong tactile resistance.The catheter was then removed from the patient.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6654559
• MDR Text Key: 78073796
• Report Number: 1018233-2017-03202
• 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,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 1758SI18
• Device Lot Number: NGZH2265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1