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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 TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 365302
Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Exposure to Body Fluids (1745)
Event Date 11/25/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: bd received a contaminated sample, photo, and video for investigation.The video and photo were evaluated and blood was observed on the bottom outside of the tube.The returned sample was washed and observed under magnification for signs of damage that may allow blood to leak from the tube.No damage was found.Additionally, one hundred (100) retention samples from bd inventory, were evaluated by visual examination and no issues were observed relating to damage that may lead to this indicated failure.All retention 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 of damaged tube leading to blood leakage.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.Our business team regularly reviews the collected data for identification of emerging trends.".
 
Event Description
It was reported that 2 bd vacutainer® sst¿ ii advance plus blood collection tubes cracked and had missing additive.The following information was provided by the initial reporter: "after centrifugation the clot got out of the tube ( maybe a hole in the bottom of the tube) ".
 
Manufacturer Narrative
Investigation summary: bd received a contaminated sample, photo, and video for investigation.The video and photo were evaluated and blood was observed on the bottom outside of the tube.The returned sample was washed and observed under magnification for signs of damage that may allow blood to leak from the tube.No damage was found.Additionally, one hundred (100) retention samples from bd inventory, were evaluated by visual examination and no issues were observed relating to damage that may lead to this indicated failure.All retention 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 of damaged tube leading to blood leakage.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.Our business team regularly reviews the collected data for identification of emerging trends.".
 
Event Description
It was reported that 2 bd vacutainer® sst¿ ii advance plus blood collection tubes cracked and had missing additive.The following information was provided by the initial reporter: "after centrifugation the clot got out of the tube ( maybe a hole in the bottom of the tube) ".
 
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Brand Name
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK 
Manufacturer (Section G)
BECTON, DICKINSON AND COMPANY (BD)
belliver way
belliver industrial estate
plymouth
UK  
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13047403
MDR Text Key285854216
Report Number9617032-2021-01305
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
BK050036
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
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2022
Device Catalogue Number365302
Device Lot Number1020088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2021
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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