MAUDE Adverse Event Report: BARD SHANNON LIMITED FIXT SUTURING DEVICE

Catalog Number SD105

Device Problems Break (1069); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported that the device was tested outside the pt, it worked fine.When they tried to place the suture in the pt, it did not work, the bullet was not captured.The surgeon tried to pull the suture out of the pt but the bullet was in the ligament.When they pulled on the suture, the suture broke, leaving the bullet stuck in the ligament.The surgeon was unable to find the bullet for removal.They tried again with another suture, and this time the bullet did catch and the surgery was able to proceed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

• Brand Name: FIXT SUTURING DEVICE
• Manufacturer (Section D): BARD SHANNON LIMITED; humacao PR
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, rd #3, km 79.7; humacao PR 00791
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4412394
• MDR Text Key: 5278481
• Report Number: 1018233-2015-00006
• Device Sequence Number: 1
• Product Code: GDF
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SD105
• Device Lot Number: HUXJ1161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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