MAUDE Adverse Event Report: GREATBATCH MEDICAL VIAPEEL PTFE PEELABLE INTRODUCERS; VIAPEEL PTFE PEELABLE INTRODUCERS,

Model Number 10890-014

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2018

Event Type  malfunction  

Event Description

A pharmacist at (b)(6) informed cook on (b)(6) 2018 of an incident involving a turbo-ject standard power injectable picc line from lot# 9027012.During a picc line insertion procedure, it was noticed that the wings allowing the removal of the peel away introducer were coming off.This defect caused difficulties in removing the introducer leading to a 5 min longer procedure.However, the surgeon managed to place the catheter.

• Brand Name: VIAPEEL PTFE PEELABLE INTRODUCERS
• Type of Device: VIAPEEL PTFE PEELABLE INTRODUCERS,
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518115
• MDR Report Key: 8508678
• MDR Text Key: 141746669
• Report Number: 2183787-2019-00032
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2019

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
• Device Operator: Health Professional
• Device Model Number: 10890-014
• Device Lot Number: VN4120286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1