MAUDE Adverse Event Report: TELEFLEX MEDICAL VCLUDE TI MED 24/CART 25/BOX; CLIP, IMPLANTABLE

Catalog Number 40425S

Device Problem Material Fragmentation (1261)

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

Fragments of plastic from cartridge are being removed in the clips.

Manufacturer Narrative

Qn# (b)(4).A dhr review could not be performed since the lot number was not provided.The complaint sample was not returned for investigation.Therefore, the root cause cannot be established.The complaint sample was not returned for investigation.A dhr review could not be performed since the lot number was not provided.Therefore, the root cause cannot be established.

Event Description

Fragments of plastic from cartridge are being removed in the clips.

• Brand Name: VCLUDE TI MED 24/CART 25/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14353888
• MDR Text Key: 291818688
• Report Number: 3011137372-2022-00087
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 40425S
• Device Lot Number: NO LOT NUM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2022
• 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: A
• Patient Sequence Number: 1