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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 368969
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that the bd vacutainer® sst¿ ii advance plus blood collection tube has been found experiencing tube push off during use.The following has been provided by the initial reporter: the ivf ward complained that the tubes are jumping out of the holder while taking the blood.The nurse who draws the blood said that she needs to hold the tube firmly in order to keep it inside the holder while drawing blood.
 
Event Description
It has been reported that the bd vacutainer® sst¿ ii advance plus blood collection tube has been found experiencing tube push off during use.The following has been provided by the initial reporter: the ivf ward complained that the tubes are jumping out of the holder while taking the blood.The nurse who draws the blood said that she needs to hold the tube firmly in order to keep it inside the holder while drawing blood.
 
Manufacturer Narrative
Investigation summary bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for stopper pullout with the incident lot was not observed.Additionally, retention samples were selected from bd inventory for testing and upon completion, no issues were observed relating to stopper pullout as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
 
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Brand Name
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
MDR Report Key9536821
MDR Text Key187617595
Report Number9617032-2019-01594
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
PMA/PMN Number
BK050036
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 03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2020
Device Catalogue Number368969
Device Lot Number9106811
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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