MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367957

Device Problems Short Fill (1575); Volume Accuracy Problem (1675); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

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 the bd vacutainer¿ sst" ii advance plus blood collection tubes experienced: a)underfill or low draw of a tube with blood.B)poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: "they reported it did not collect full 3.5ml blood amount (3.5ml), they had to have subject return for additional collection.And the gel did not seem to act as a barrier after the centrifugation.".

Event Description

It was reported the bd vacutainer® sst¿ ii advance plus blood collection tubes experienced: underfill or low draw of a tube with blood.Poor barrier separation of sample.The following information was provided by the initial reporter.The customer stated: "they reported it did not collect full 3.5ml blood amount (3.5ml), they had to have subject return for additional collection.And the gel did not seem to act as a barrier after the centrifugation.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples (material #367957, lot #0084228), but photos were provided for investigation.The photos were reviewed and the indicated failure mode for poor barrier separation with the incident lot was observed.Four retention samples from bd inventory were evaluated by functional testing and the issue of poor barrier separation was not observed.Additionally, 20 retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not observed.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.

• 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
• MDR Report Key: 11545978
• MDR Text Key: 250029224
• Report Number: 9617032-2021-00257
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679572
• UDI-Public: 50382903679572
• Combination Product (y/n): Y
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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 Date: 09/30/2021
• Device Model Number: 367957
• Device Catalogue Number: 367957
• Device Lot Number: 0084228
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/22/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1