MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILVER LUBRISIL TSC TRAY WITH BACTERIOSTATIC IC DRAINAGE BAG AND OTHER COMPONENT; FOLEY CATHETER (LATEX)

Catalog Number 919214

Device Problems Contamination (1120); Gel Leak (1267); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2020

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 a leak occurred.It was unknown what and where it leaked.Per additional information from the ibc via email 03feb2020; there is a red/brown stain on the iodine packet, catheter lubricant packet, and one glove.The stain could be a leak in the iodine packet.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Evaluation found there was brown jelly-like material on the pvi package, jelly package, glove and the tray.The origin of the brown jelly-like material was unknown.A potential root cause for this failure mode could be user related (handling issue)/ defect component from supplier.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: "contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.]" 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.

Event Description

It was reported that a leak occurred.It was unknown what and where it leaked.Per additional information from the ibc via email 03feb2020; there is a red/brown stain on the iodine packet, catheter lubricant packet, and one glove.The stain could be a leak in the iodine packet.

• Brand Name: SILVER LUBRISIL TSC TRAY WITH BACTERIOSTATIC IC DRAINAGE BAG AND OTHER COMPONENT
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9739341
• MDR Text Key: 184151409
• Report Number: 1018233-2020-01227
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

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 Expiration Date: 11/28/2022
• Device Catalogue Number: 919214
• Device Lot Number: NGDP1880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1