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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Model Number 366703
Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
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.
 
Event Description
It was reported when using the bd vacutainer® no additive (z) tube there was foreign matter in the tube(s) biological and non-biological and stopper creep out or loose closure.The following information was provided by the initial reporter.The customer stated: "the following issues were found in tubes: (1) black spots on tube ×5.(2) loose cap ×4.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 11/1/2021.H6: investigation: bd received nine (9) samples and eight (8) photos for investigation.The photos and samples were reviewed and the customer¿s indicated failure mode for embedded foreign matter (fm) was observed.The tubes expired on (b)(6) 2021 and could not be evaluated for the customer's indicated failure mode of loose caps.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.This complaint has been confirmed for the indicated failure mode of embedded fm based on returned photos and samples.The complaint could not be confirmed for the indicated failure mode of loose caps as the tubes had expired and could not be evaluated.Bd was not able to identify a root cause for the loose caps.Bd was able to determine that the embedded fm is attributed to resin colorant and/or resin adhering to the interior of the mold core and breaking free during production.H3 other text: see h10.
 
Event Description
It was reported when using the bd vacutainer® no additive (z) tube there was foreign matter in the tube(s) biological and non-biological and stopper creep out or loose closure.The following information was provided by the initial reporter.The customer stated: "the following issues were found in tubes: black spots on tube ×5.Loose cap ×4.".
 
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Brand Name
BD VACUTAINER® NO ADDITIVE (Z) TUBES
Type of Device
SPECIMEN TRANSPORT AND STORAGE CONTAINER
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12634732
MDR Text Key277181553
Report Number1917413-2021-00902
Device Sequence Number1
Product Code FMH
UDI-Device Identifier50382903667036
UDI-Public50382903667036
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Model Number366703
Device Catalogue Number366703
Device Lot Number0044096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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