• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UNKNOWN DUMMY MATERIAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL OEM UNKNOWN DUMMY MATERIAL Back to Search Results
Catalog Number OEM UNKNOWN
Device Problem Activation, Positioning or SeparationProblem (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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOEM 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 Key6210066
MDR Text Key63712151
Report Number3004365956-2016-00465
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberOEM UNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2016
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

-
-