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

Model Number	0196L22
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2019
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 catheter fell out of the patient with a large slit found on the balloon.Per sample evaluation, it was found that the catheter datecode appeared to have a printing error, the catheter packaging was missing an expiration date, and according to the (b)(6), the catheter was expired.
Additional Manufacturer Narrative
The reported event was confirmed as a packaging related issue.A red rubber two way lubricath catheter was returned with a 10 cc slip tip syringe with its original packaging.In the investigation, it was found that the 76cm0118 release date 06aug2004 does not match the lot number format according to the standard.Also it was found that the expiration date was missing.A potential root cause for this issue could be "operator error" error during the label printing process".The packaging failed specifications.There does appear to be a relationship between the event and the packaging as the lot was found to be in an incorrect format and the expiration date was missing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not completed as it unlikely the user would cause this issue.
Event or Problem Description
It was reported that the catheter fell out of the patient with a large slit found on the balloon.Per sample evaluation, it was found that the catheter datecode appeared to have a printing error, the catheter packaging was missing an expiration date, and according to the nogales jde search, the catheter was expired.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL
• Common Device Name: LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9653528
• Report Number: 1018233-2020-00687
• Device Sequence Number: 2511968
• Product Code: EZC
• UDI-Device Identifier: 00801741017957
• UDI-Public: (01)00801741017957
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/20/2020

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: 03/31/2007
• Device Model Number: 0196L22
• Device Catalogue Number: 0196L22
• Device Lot Number: 76CM0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1