MAUDE Adverse Event Report: TELEFLEX MEDICAL VLOCK XLG CLIP 6/CART 14/BOX; CLIP, IMPLANTABLE

Catalog Number 71114V

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that white plastic for clipping was found twice in the patient's body.One time i broke it the moment i plugged it in.

Manufacturer Narrative

(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint number 3011137372-2019-00268 is being reported as a malfunction.There was no serious injury.

• Brand Name: VLOCK XLG CLIP 6/CART 14/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8936302
• MDR Text Key: 155707422
• Report Number: 3011137372-2019-00268
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71114V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention