MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP TTL1LYR 16FR10ML 100%SILI UMST TR

Model Number	URO170816S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the nurse attempted to place a foley catheter in a patient and after completing the procedure, inflated the balloon with 10mls and pulled back on the catheter the catheter just came out.
Additional Manufacturer Narrative
It was reported that the nurse attempted to place a foley catheter in a patient and after completing the procedure, inflated the balloon with 10mls and pulled back on the catheter the catheter just came out.The nurse then proceeded to grab another kit and this time prefilled the balloon to see what would happen.The second attempt the balloon of the catheter exploded after the nurse put in more than 5ml's.The procedure was attempted again and the nurse put in 5ml's of fluid with success.The patient currently has a foley in with only 5mls in the balloon.The catheters that the nurse had issues with were discarded and are not available to be returned for evaluation.No additional information is available.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.

• Brand Name: TTL1LYR 16FR10ML 100%SILI UMST TR
• Common Device Name: TTL1LYR 16FR10ML 100%SILI UMST 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: 15136756
• Report Number: 1417592-2022-00126
• Device Sequence Number: 7295883
• Product Code: OHR
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/30/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: URO170816S
• Device Catalogue Number: URO170816S
• Device Lot Number: 22DBK031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/30/2022
• 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: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 64 KG