MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 16FR10ML 100%SIL TMPST TR

Catalog Number	URO180816TS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the catheter was leaking so the nurse checked the balloon and there was only 8ml in the balloon.The nurse re-inflated the balloon to ensure that the balloon had a total of 10ml in the balloon however the catheter continued to leak so the nurse removed the foley catheter and inserted a new foley catheter.The nurse noted that the second catheter was fully inflated and seated in the bladder however the leaking continued so the catheter was removed.It was not reported that an additional catheter was placed.The catheter was returned to the manufacturer for evaluation and the customer reported issue of a leaking foley catheter balloon could not be confirmed through functional evaluation of the received sample.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
The customer reported that the foley catheter balloon was leaking so the nurse removed the foley catheter and replaced the device with a new catheter.

• Common Device Name: TTL1LYR 16FR10ML 100%SIL TMPST TR
• 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: 13404904
• Report Number: 1417592-2022-00007
• Device Sequence Number: 17665027
• Product Code: OHR
• UDI-Device Identifier: 10889942127955
• UDI-Public: 10889942127955
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: URO180816TS
• Device Lot Number: 21CBE450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/31/2022
• 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: Required Intervention
• Patient Sex: Unknown