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

Model Number 175808

Device Problems Crack (1135); Fracture (1260); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); 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 there was a crack at the y connector which caused the catheter to leak.The catheter was reportedly replaced.

Event Description

It was reported that there was a crack at the y connector which caused the catheter to leak.The catheter was reportedly replaced.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 70:30.The balloon rested for 30 minutes without leaks and passively deflated without issue, returning 10ml of solution.No cuffing was noted.The drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water), and immediately leaked from a pinhole (measuring 0.012 inches) at the bifurcation point.This is out of specification per inspection procedure which states, "no holes, rips, or cracks in components are allowed (inspection from 18 inch distance)." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿inserts with edges (operator hits the tube against the bottom insert when removing the piece from the mold).¿ 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: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." 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: 9985449
• MDR Text Key: 188823586
• Report Number: 1018233-2020-02761
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034275
• UDI-Public: (01)00801741034275
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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 Model Number: 175808
• Device Catalogue Number: 175808
• Device Lot Number: NGDT2778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1