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

Model Number	0196L22
Medical Device Problem Code	Expiration Date Error (2528)
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 nogales jde search, the catheter was expired.
Additional Manufacturer Narrative
The reported event was confirmed, however, the cause is unknown.A red rubber two way lubricath catheter was returned with a 10 cc slip tip syringe with its original packaging.In the investigation, its dhr review showed that the product expired on 31march2007 which are years before the date of awareness.As no expiration date was found on the package and the box label was not returned this investigation cannot be confirmed as use-related.A potential root cause for this issue could be "operator error" during the label printing process".As the expiration date was missing from the packaging and the box label was not returned, it cannot be determined if the device failed to met specifications.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 the event states that the expiration date was missing from the package and the box label cannot be retrieved to the lot age.
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: 9653530
• Report Number: 1018233-2020-00688
• Device Sequence Number: 11390763
• 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