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

Model Number	01237524
Medical Device Problem Code	Deflation Problem (1149)
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 inconclusive as no sample was returned for evaluation.The potential root cause could be due to a "kinked lumen".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: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst".Correction: d4, d10 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.H3 other text : the device was not returned.
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: 9416524
• Report Number: 1018233-2019-07742
• Device Sequence Number: 13953551
• 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): 01/30/2020

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: MCDR2227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1