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 & CO., (BD) BD VACUTAINER NO ADDITIVE (Z) PLUS TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER
  • 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 & CO., (BD) BD VACUTAINER NO ADDITIVE (Z) PLUS TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Catalog Number 366408
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported the bd vacutainer® no additive (z) plus tubes had the stopper pop out of the tube.The following information was provided by the initial reporter: translated to english.The customer stated :caps are popping off during transport and spilling (tubes are half to 3/4 full).Sometimes the plastic part of the cap separates from the rubber stopper.Note: these tubes are used for aliquots so the caps are not staying on while reapplied.The non-additive tube cap goes back on but is super easy to pull off, with very little resistance.The original stoppers are popping off or coming apart (rubber stopper and clear cap separating).".
 
Event Description
It was reported the bd vacutainer® no additive (z) plus tubes had the stopper pop out of the tube.The following information was provided by the initial reporter: translated to english.The customer stated :caps are popping off during transport and spilling (tubes are half to 3/4 full).Sometimes the plastic part of the cap separates from the rubber stopper.Note: these tubes are used for aliquots so the caps are not staying on while reapplied.The non-additive tube cap goes back on but is super easy to pull off, with very little resistance.The original stoppers are popping off or coming apart (rubber stopper and clear cap separating).".
 
Manufacturer Narrative
H6: investigation summary bd received ten (10) samples from the customer for investigation.All samples were evaluated by functional testing and the indicated failure mode for stopper pop-off with the incident lot was observed.Bd was unable to determine the root cause of the customer's issue.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 issues during manufacturing of the product.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VACUTAINER NO ADDITIVE (Z) PLUS TUBES
Type of Device
SPECIMEN TRANSPORT AND STORAGE CONTAINER
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key10857711
MDR Text Key230744690
Report Number1024879-2020-00854
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2021
Device Catalogue Number366408
Device Lot Number0218172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-