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

Catalog Number 367953

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Expiration Date Error (2528)

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

Event Date 03/24/2022

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 when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced poor barrier separation.The following information was provided by the initial reporter.The customer stated: when centrifuged in 2000g for 10 minutes, the gel doesn't go up and does not separate the serum from the blood.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced poor barrier separation and tubes being used after expiration.The following information was provided by the initial reporter.The customer stated: when centrifuged in 2000g for 10 minutes, the gel doesn't go up and does not separate the serum from the blood.Additional information -2022-04-08 tubes expired 28feb2022.

Manufacturer Narrative

B.5.Event description: it was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced poor barrier separation and tubes being used after expiration.The following information was provided by the initial reporter.The customer stated: when centrifuged in 2000g for 10 minutes, the gel doesn't go up and does not separate the serum from the blood.Additional information -2022-04-08 tubes expired 28feb2022.Imdrf annex a grid (1) : a210101.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes, the device experienced poor barrier separation and tubes being used after expiration.The following information was provided by the initial reporter.The customer stated: when centrifuged in 2000g for 10 minutes, the gel doesn't go up and does not separate the serum from the blood.Additional information -2022-04-08 tubes expired 28feb2022.

Manufacturer Narrative

H6: investigation summary: bd had not received samples or photos for evaluation.The expiry date of the lot number was february 2022.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because the tubes has expired.Bd makes no claims on expired materials.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 poor barrier separation.Bd was not able to identify a root cause for the indicated failure mode.

• 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 Key: 13999088
• MDR Text Key: 288623221
• Report Number: 9617032-2022-00279
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679539
• UDI-Public: 00382903679539
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2022

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: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 367953
• Device Lot Number: 0240262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/28/2022; 05/06/2022
• Supplement Dates FDA Received: 05/04/2022; 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1