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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ONCONTROL PORTED ASPIRATION TRAY (BX/6) BIOPSY NEEDLE KIT

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TELEFLEX MEDICAL ONCONTROL PORTED ASPIRATION TRAY (BX/6) BIOPSY NEEDLE KIT Back to Search Results
Catalog Number 9471-VC-006
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that when they opened the tray, the sterile procedure bag had a hole in it.
 
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Brand NameONCONTROL PORTED ASPIRATION TRAY (BX/6)
Type of DeviceBIOPSY NEEDLE KIT
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key8901791
MDR Text Key154578718
Report Number3011137372-2019-00247
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 07/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/23/2022
Device Catalogue Number9471-VC-006
Device Lot Number30668588
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 Received07/22/2019
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

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