MAUDE Adverse Event Report: TELEFLEX MEDICAL VISISTAT 35W 6/BOX; STAPLE,REMOVABLE (SKIN)

Catalog Number 528235

Device Problems Loss of or Failure to Bond (1068); Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product visistat 35w 6/box, lot number 73h1500255 investigations did not show issues related to the complaint.The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the packages are not sealed properly and sterility cannot be assured.The issue was noted during in-coming inspection.

Manufacturer Narrative

(b)(4).The customer returned one sealed unit 528235 visistat 35w 6/box from lot number 73h1500255 for investigation.Visual examination revealed that there appears to be a sealing issue along the upper left corner of the lidstock with the stapler package laid lidstock side down.Reference files (b)(4) for investigation photos.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.The reported complaint of an improperly sealed package was confirmed based upon the samples received.Based on the observed defect, the probable cause for this complaint issue is packaging related.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.The samples have been forwarded to the manufacturing site for further investigation.

Event Description

Alleged event: the packages are not sealed properly and sterility cannot be assured.The issue was noted during in-coming inspection.

• Brand Name: VISISTAT 35W 6/BOX
• Type of Device: STAPLE,REMOVABLE (SKIN)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5594350
• MDR Text Key: 43212223
• Report Number: 3003898360-2016-00391
• Device Sequence Number: 1
• Product Code: GDT
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Catalogue Number: 528235
• Device Lot Number: 73H1500255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2015
• 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