MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTLVENT 14FR10ML 100%SIL DB TR

Catalog Number	URO180714
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient with an indwelling catheter inserted pulled on the catheter and broke the catheter off below the neck of the balloon while the catheter was still inserted.The catheter was retained in the bladder requiring a cystoscopy to remove 16 cm of the catheter from the bladder.According to the customer the patient did not sustain any permanent trauma related to the incident.There was no additional medical intervention or follow up care required.The sample was discarded at the hospital and is not available to be returned for evaluation.Due to the need for surgical intervention during the reported incident, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient with an indwelling catheter inserted pulled on the catheter and broke the catheter off below the neck of the balloon while still inserted requiring surgical removal.

• Common Device Name: TTLVENT 14FR10ML 100%SIL DB TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10242234
• Report Number: 1417592-2020-00049
• Device Sequence Number: 14163620
• Product Code: OHR
• UDI-Device Identifier: 10889942687077
• UDI-Public: 10889942687077
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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 Catalogue Number: URO180714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Weight: 69