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

Model Number	0102L18
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	Urinary Retention (2119); No Information (3190)
Type of Reportable Event	Serious Injury
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 foley catheter was inserted into a patient and there was no urine output.A bladder scan was reportedly performed, and revealed significant urine in the bladder.The catheter was reportedly replaced and over 300 cc of urine drained.Upon removal, it was noted that there was no exit hole on the foley.The catheter was reportedly in use for just over 24 hours.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.A red rubber lubricath catheter was returned without its original packaging.No drainage eyes were found on the catheter.The root cause of this failure is operator error during the eyes burning process due to which the drainage eyes were absent, resulting in no urine flow with potential injury to bladder.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." correction: d4 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 the foley catheter was inserted into a patient and there was no urine output.A bladder scan was reportedly performed, and revealed significant urine in the bladder.The catheter was reportedly replaced and over 300cc of urine drained.Upon removal, it was noted that there was no exit hole on the foley.The catheter was reportedly in use for just over 24 hours.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9612508
• Report Number: 1018233-2020-00464
• Device Sequence Number: 16274662
• Product Code: EZC
• UDI-Device Identifier: 00801741018138
• UDI-Public: (01)00801741018138
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: 0102L18
• Device Catalogue Number: 0102L18
• Device Lot Number: MCDN0795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention