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

Model Number	01237524
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 two foley balloons deflated prematurely during use.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.An amber lubricath catheter was returned without its original packaging.The balloon appeared to have sticky residue on its shaft.A 10 cc leur lock syringe was used to attempt to inflate the catheter with 80 ccs of air.During the 60 cc inflate, the catheter spontaneously deflated.The catheter was then attempted to be inflated with 80 ccs of water; water immediately began to leak from the tip of the catheter.Upon closer examination, it was found that the water was leaking from the drainage eye.A potential root cause for this failure could be "lumen compromised by a puncture or cut".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." 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 or Problem Description
It was reported that two foley balloons deflated prematurely during use.No medical intervention was reported.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: LUBIR CATH VALVE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9416048
• Report Number: 1018233-2019-07740
• Device Sequence Number: 2922626
• Product Code: EZC
• UDI-Device Identifier: 00801741017742
• UDI-Public: (01)00801741017742
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: 01237524
• Device Catalogue Number: 01237524
• Device Lot Number: EW9271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1