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

Catalog Number 368498

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Air/Gas in Device (4062)

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

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 that while using bd vacutainer® sst¿ ii advance plus blood collection tubes that there is air bubble in gel.The following information was provided by the initial reporter: bubbles in gel, has occurred at 5 different occasions.

Manufacturer Narrative

The following fields have been updated with corrected information: b.5.Describe event or problem: it was reported that while using bd vacutainer® sst¿ ii advance plus blood collection tubes that there is air bubble in gel.This is the 2nd of 2 events.The following information was provided by the initial reporter: bubbles in gel.H.6 imdrf annex a code: a1415.H.6.Investigation summary: bd had not received samples, but 1 photos was provided for investigation.The photo was reviewed and the indicated failure mode for gel air bubbles was observed.Additionally, 180 retention samples from bd inventory were visually inspected for gel air bubbles.1 tube had gel air bubbles.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 has been confirmed for gel air bubbles based on the photo and retention sample inspection.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 while using bd vacutainer® sst¿ ii advance plus blood collection tubes that there is air bubble in gel.This is the 2nd of 2 events.The following information was provided by the initial reporter: bubbles in gel.

Event Description

It was reported that while using bd vacutainer® sst¿ ii advance plus blood collection tubes that there is air bubble in gel.This is the 2nd of 2 events.The following information was provided by the initial reporter: bubbles in gel.

Manufacturer Narrative

The following fields have been updated with additional/corrected information: the following fields were updated due to additional information: d9: device available for evaluation:  yes.D9: returned to manufacturer on:  2023-08-24.H.1.Imdrf annex b grid : b01 - testing of actual/suspected device.H.1.Device return to manuf : yes.H.1.Device eval by manufacturer: yes.H.6.Investigation summary: bd received one photograph and ten (10) samples from the customer in support of this complaint.Evaluation of both indicated 10 tubes with bubbles in the gel.Additionally, 180 retention samples from bd inventory were visually inspected for gel air bubbles.1 tube had gel air bubbles.Complaints for sample quality are under statistical control for the month of july 2023.At this time, further testing is not indicated.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 has been confirmed for gel air bubbles based on the photo, return, and retention sample inspection.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17421948
• MDR Text Key: 320081209
• Report Number: 9617032-2023-00989
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368498
• Device Lot Number: 3086937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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