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

Model Number 175816

Device Problem Deflation Problem (1149)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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 balloon on the foley catheter would not deflate during a clinical assessment.

Event Description

It was reported that the balloon on the foley catheter would not deflate during a clinical assessment.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.Visual evaluation of all four photo samples noted one opened (with some original packaging), silicone foley catheter portion.Visual inspection of the photo sample noted the balloon of catheter appeared inflated and severely asymmetrical from all angles.Balloon concentricity was observed to be approximately 80:20 which is out of specification.Without the physical sample to evaluate, it is unknown if the catheter experienced difficulties with inflation or deflation.A potential root cause for the reported failure could be, ¿high balloon gauge.¿ 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: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use." correction: d4, e1, e3.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.

• 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 GA 30014
• MDR Report Key: 9519622
• MDR Text Key: 177997896
• Report Number: 1018233-2019-08231
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGDS2124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1