Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE
  • 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
 

BECTON DICKINSON MEDICAL (SINGAPORE) BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE Back to Search Results
Catalog Number 301746
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation summary: bd had not received samples or photos from the customer for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.Bd has initiated further root cause investigation relating to the issue of sleeve leakage through a corrective and preventive action (capa).
 
Event Description
It was reported when using the bd vacutainer® flashback blood collection needle there was foreign matter on the device cannula/ needle or any fluid path component.The following information was provided by the initial reporter: translated to english.The customer stated: "before use,it found that 1ea fbn's needle point has burred.".
 
Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for evaluation.A review of the dhr indicated a quality notification was raised for this issue.However,lot passed all in-process and final quality checks for lot release.There was an action implemented to clean the seal pin with 70% ipa followed by a clean lint free cloth during weekly pm.This action was completed on 11-dec-2020.This batch was produced before the implementation date.
 
Event Description
It was reported when using the bd vacutainer® flashback blood collection needle there was foreign matter on the device cannula/ needle or any fluid path component.The following information was provided by the initial reporter: translated to english.The customer stated: "before use,it found that 1ea fbn's needle point has burred.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE
Type of Device
BLOOD COLLECTION NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key11379641
MDR Text Key241964690
Report Number8041187-2021-00129
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2022
Device Catalogue Number301746
Device Lot Number0275050
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-