MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® PEDIATRIC FOLEY CATHETER; BARDEX FOLEY CATHETER

Model Number	0165PL08
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the foley catheter ballooned in two areas.
Event or Problem Description
It was reported that the foley catheter ballooned in two areas.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.The visual evaluation observed a flat/blown area on the lumen that created a balloon on the shaft.The sample was examined under a microscope and was identified to be related to the manufacturing process.The device history record was reviewed and found a possible manufacturing issue(s) 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.]" 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® LUBRICATH® PEDIATRIC FOLEY CATHETER
• Common Device Name: BARDEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8298991
• Report Number: 1018233-2019-00561
• Device Sequence Number: 13464479
• Product Code: EZC
• UDI-Device Identifier: 00801741017667
• UDI-Public: (01)00801741017667
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: 0165PL08
• Device Catalogue Number: 0165PL08
• Device Lot Number: 7GM0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1