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

Catalog Number 368965

Device Problems Difficult to Insert (1316); Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

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 while using bd vacutainer® sst¿ ii advance plus blood collection tubes the tube pushes off the non patient end of needle and tubes are under filling.The patient impact was not reported.The following information was provided by the initial reporter: when the user push the tube in the holder, the tube is rejected and jump outside of the holder sometime it is also not well filled.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-04.H6: investigation summary: bd received 25 samples from the customer for investigation.The samples were evaluated by functional testing and the indicated failure mode for tube push off with the incident lot was not observed as all product specifications were met.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 non-conformances during manufacturing of the product.Bd received 20 samples from the customer for investigation.All samples were evaluated by functional testing and the tubes were able to draw without any issues as all product specifications were met.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 non-conformances during manufacturing of the product.

Event Description

It was reported while using bd vacutainer® sst¿ ii advance plus blood collection tubes the tube pushes off the non patient end of needle and tubes are under filling.The patient impact was not reported.The following information was provided by the initial reporter: when the user push the tube in the holder, the tube is rejected and jump outside of the holder sometime it is also not well filled.

• 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: 11098101
• MDR Text Key: 224538403
• Report Number: 9617032-2020-01085
• Device Sequence Number: 1
• Product Code: JKA
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 368965
• Device Lot Number: 0230276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1