MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY CAUTI TEMP SENS MF 16FR 10ML SAFE

Catalog Number	URO170816TSQ
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	12/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Syringe broke while inflating foley catheter balloon.
Additional Manufacturer Narrative
It was reported by the customer contact that on (b)(6) 2023, "urine started coming out around the catheter as well as into the tubing.When rn went to inflate the balloon, the syringe broke and urine and saline splashed into my eyes, onto my face, and onto my clothing." no additional information is available at this time.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
Including additional possible lot numbers: 23hbd446, 23hbj858, 23hbu372, 23ibo170.

• Common Device Name: TRAY CAUTI TEMP SENS MF 16FR 10ML SAFE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18466941
• Report Number: 1417592-2024-00017
• Device Sequence Number: 3100822
• Product Code: OHR
• UDI-Device Identifier: 10193489723427
• UDI-Public: 10193489723427
• 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): 02/12/2024

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
• Device Catalogue Number: URO170816TSQ
• Device Lot Number: 23DBO314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/12/2024
• 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