MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 14FR10ML 100%SILI DB TRA

Catalog Number	URO170714
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by the customer contact that, "foley became under tension during a patient fall.The device was noted to be missing the balloon portion after unplanned removal".It was reported that due to this, "bedside ultrasound to confirm retained foreign object and placement of new foley.As well urology irrigated the bladder to aid in flushing of the foreign object".It was reported "there was not any patient harm as a direct result of the catheter failure".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.
Event or Problem Description
"balloon portion" of foley catheter missing after foley was "placed under tension".

• Common Device Name: TTL1LYR 14FR10ML 100%SILI DB TRA
• 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: 18418661
• Report Number: 1417592-2023-00527
• Device Sequence Number: 7846743
• Product Code: OHR
• UDI-Device Identifier: 10888277866928
• UDI-Public: 10888277866928
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 12/29/2023

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
• Device Catalogue Number: URO170714
• Device Lot Number: 23ABT042, 23HBD442, 23JBE050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (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