MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER SST II ADVANCE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367957

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

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.(b)(4).

Event Description

It was reported that after centrifugation with bd vacutainer® sst¿ ii advance gel smearing occurred.This occurred on 10 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: gel issues description of the problem: the gel after centrifugation stretches / flows / delaminates / disintegrates.Clods / balls formed, clog and stick to the outside, analyzer needle (cobas).

Event Description

It was reported that after centrifugation with bd vacutainer® sst¿ ii advance gel smearing occurred.This occurred on 10 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: gel issues description of the problem: the gel after centrifugation stretches / flows / delaminates / disintegrates clods / balls formed, clog and stick to the outside, analyzer needle (cobas).

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-03.H6: investigation summary bd received 4 samples and 7 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for gel globules with the incident lot was observed.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for gel globules with the incident lot was 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
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 11386953
• MDR Text Key: 250168256
• Report Number: 9617032-2021-00195
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679572
• UDI-Public: 50382903679572
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 367957
• Device Catalogue Number: 367957
• Device Lot Number: 0245288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1