MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TL1LYR 14FR10ML LATEX DB SAFES

Model Number	URO170114Q
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2023, the end of the syringe "broke off" in the foley port and a new catheter was required to be inserted.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023, the end of the syringe "broke off" in the foley port and a new catheter was required to be inserted.The customer reported there was no serious injury or additional medical intervention required related to the reported incident.Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Additional Manufacturer Narrative
Investigation conclusions.

• Brand Name: MEDLINE
• Common Device Name: TL1LYR 14FR10ML LATEX DB SAFES
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16869874
• Report Number: 1417592-2023-00200
• Device Sequence Number: 5386108
• Product Code: OHR
• UDI-Device Identifier: 10193489442120
• UDI-Public: 10193489442120
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: URO170114Q
• Device Catalogue Number: URO170114Q
• Device Lot Number: 23BBA094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 06/11/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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