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U.S. Department of Health and Human Services

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

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GREATBATCH MEDICAL VIAPEEL PTFE PEELABLE INTRODUCERS; VIAPEEL PTFE PEELABLE INTRODUCERS, Back to Search Results
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.
 
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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 Key8508678
MDR Text Key141746669
Report Number2183787-2019-00032
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072248
Number of Events Reported1
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 Number10890-014
Device Lot NumberVN4120286
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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