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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 363083
Device Problems Short Fill (1575); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2023
Event Type  malfunction  
Event Description
It was reported that during use with bd vacutainer® buffered sodium citrate (9nc) blood collection tubes air bubbles form causing tube to underfill.There was no report of patient impact.The following information was provided by the initial reporter: customer is reporting bubbles form when filling tubes causing them to underfill.Affected lot number 3048743.
 
Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 28-aug-2023.H.6.Investigation summary: bd received 10 samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for underfill with the incident lot was not observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill as all samples met specifications.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.This complaint is unable to be confirmed for the indicated failure mode underfill.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that during use with bd vacutainer® buffered sodium citrate (9nc) blood collection tubes air bubbles form causing tube to underfill.There was no report of patient impact.The following information was provided by the initial reporter: customer is reporting bubbles form when filling tubes causing them to underfill.Affected lot number 3048743.
 
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Brand Name
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17590805
MDR Text Key321744970
Report Number1917413-2023-00823
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903630832
UDI-Public50382903630832
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2023
Device Catalogue Number363083
Device Lot Number3048743
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/07/2023
Initial Date FDA Received08/21/2023
Supplement Dates Manufacturer Received09/07/2023
Supplement Dates FDA Received09/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2023
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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