MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER; 5 CC LUBRICATH

Model Number	0165L22
Medical Device Problem Code	Material Deformation (2976)
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.The device was not returned.
Event or Problem Description
It was reported that the catheter did not drain properly, which caused urine to leak around it.The balloon filled unevenly, and when deflating after being filled with 10cc, only 3cc came out.No medical intervention was required.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could be due to "balloon molding".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the catheter was inflated with the correct amount of ccs (10), the reported event would most likely not be caused by the user.Therefore a labeling review was not completed.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 the catheter did not drain properly, which caused urine to leak around it.The balloon filled unevenly, and when deflating after being filled with 10cc, only 3cc came out.No medical intervention was required.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: 5 CC LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9497984
• Report Number: 1018233-2019-08118
• Device Sequence Number: 2897897
• Product Code: EZC
• UDI-Device Identifier: 00801741017513
• UDI-Public: (01)00801741017513
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 0165L22
• Device Catalogue Number: 0165L22
• Device Lot Number: NGDS0361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/02/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1