MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP CATHETER,URETHRAL,REDRUBBER,STRL,18FR

Model Number	DYND13518
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the catheter broke while the surgeon was cannulating the aorta.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The two broken pieces were returned to the manufacturer for evaluation.The sample was received in an unpackaged, used condition.Visual assessment of the provided sample revealed that the catheter had been broken into 2 pieces.While the reported issue of a broken catheter could be confirmed based on visual assessment of the received sample, the initial report stated that the catheter broke while the surgeon cannulated aorta which would constitute off-label use due to the urethral catheter being meant to be used for urological purposes only.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the catheter broke while the surgeon was cannulating the aorta.No additional details are available related to the customer reported issue.

• Brand Name: CATHETER,URETHRAL,REDRUBBER,STRL,18FR
• Common Device Name: CATHETER,URETHRAL,REDRUBBER,STRL,18FR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14634532
• Report Number: 1417592-2022-00074
• Device Sequence Number: 4961315
• Product Code: KOD
• UDI-Device Identifier: 10080196031245
• UDI-Public: 10080196031245
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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 Model Number: DYND13518
• Device Catalogue Number: DYND13518
• Device Lot Number: 5922040340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown