MAUDE Adverse Event Report: TELEFLEX MEDICAL ESY-TAP LEG BG W/18 PVC TUBING

Catalog Number	453932
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be completed as no lot number was provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "patient said he got blood clots while using leg bags and they broke.Patient said the blood clot got stuck at top hose attached to leg bag and he used garden wire to try and get it unstuck, and the hose broke.Patient states bottom nozzle too tight to open.No medical intervention was reported".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.See associated mdrs #3011137372-2023-00214 and 3011137372-2023-00212.

• Brand Name: ESY-TAP LEG BG W/18 PVC TUBING
• Common Device Name: ESY-TAP LEG BG W/18 PVC TUBING
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17596149
• Report Number: 3011137372-2023-00211
• Device Sequence Number: 7364864
• Product Code: FAQ
• UDI-Device Identifier: 14026704645753
• UDI-Public: 14026704645753
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 453932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown