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

Model Number 367955

Device Problems Incorrect Measurement (1383); No Device Output (1435); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that after use with a bd vacutainer® sst¿ ii advance plus blood collection tubes gel globules are discovered after centrifugation and the gel clogged instrument probes.This also led to erroneous results and patient sample was recollected.The following information was provided by the initial reporter: according to the complaints from the hospital; gel globules are observed in the serum after sst ii tubes are centrifuged.These gel globules are block to probes of the ivd devices.Ivd devices gave incorrect result to some patients¿ tests.But nobody was affected by these results.Because doctor realized that was wrong and requested that a sample recollect again.

Event Description

It was reported that after use with a bd vacutainer® sst¿ ii advance plus blood collection tubes gel globules are discovered after centrifugation and the gel clogged instrument probes.This also led to erroneous results and patient sample was recollected.The following information was provided by the initial reporter: according to the complaints from the hospital; gel globules are observed in the serum after sst ii tubes are centrifuged.These gel globules are block to probes of the ivd devices.Ivd devices gave incorrect result to some patients¿ tests.But nobody was affected by these results.Because doctor realized that was wrong and requested that a sample recollect again.

Manufacturer Narrative

H6: investigation summary bd received 6 photos and 100 tubes for investigation.The photos showed gel globules floating in the serum.In addition, 10 returned tubes from lot number 0009399 were therefore, drawn with horse blood, mixed, stood at room temperature for 30 minutes, before being centrifuged at 1862rcf for 10 minutes, using an mse mistral 1000 centrifuge.The supernatants were then decanted and examined under magnification for any signs of gel particles or globules.None were found.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.A complaint history was performed, and this is the only complaint received on this lot number for the reported defect.The complaint is confirmed based on the photographs provided.No definitive root cause could be established for the reported defect; however it is understood that patient conditions, tube storage and processing conditions, and centrifugation settings, can impact on the quality of the serum and the presence of gel globules.Erroneous results was not evaluated further since the gel globules would be the cause of any erroneous results due to the blocked probe.

• 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: 10703487
• MDR Text Key: 213935824
• Report Number: 9617032-2020-00823
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: 0009399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other