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

Catalog Number 453932

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Teleflex will continue to monitor and trend related events.

Event Description

She does not like the bags we sent because they cause an infection on her skin.

• Brand Name: ESY-TAP LEG BG W/18 PVC TUBING
• Type of Device: 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 12149101
• MDR Text Key: 260971224
• Report Number: 3011137372-2021-00192
• Device Sequence Number: 1
• Product Code: FAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 453932
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1