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

Model Number	IPN054586
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
She does not like the bags we sent because they cause an infection on her skin.
Event or Problem Description
She does not like the bags we sent because they cause an infection on her skin.
Additional Manufacturer Narrative
Qn#: (b)(4).No device history record (dhr) was conducted due to no lot# provided, therefore; product can't be traced.No sample is available for the manufacturer to evaluate.Our products have been tested for biocompatibility.Other customers have no complaints in this respect.This may be an exceptional case.The quality department will continue to follow up.The customer may use it for a long time or have sensitive skin.The quality department will continue to follow up.

• 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
• MDR Report Key: 12100853
• Report Number: 3011137372-2021-00165
• Device Sequence Number: 11587897
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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 Model Number: IPN054586
• Device Catalogue Number: 453932
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1