MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UNKNOWN DUMMY MATERIAL

Catalog Number OEM UNKNOWN

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The device history review could not be conducted since the lot number was not provided.The complaint cannot be confirmed due the lack of a product sample and batch number to perform a proper investigation therefore the root cause is unknown.The manufacturer will continue to monitor and trend related events.

Event Description

The suture capturing device cut the suture off the bullet; on a second attempt it cut the bullet off and the bullet was stuck in the driver.The patient's condition was reported as unknown.

• Brand Name: OEM UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 6210066
• MDR Text Key: 63712151
• Report Number: 3004365956-2016-00465
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OEM UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• 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: N
• Patient Sequence Number: 1