MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER SST BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367988

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2020

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 the bd vacutainer® sst¿ blood collection tube was used after the expiration date.The following information was provided by the initial reporter the customer stated: the tubes are expired.Customer stated they used expired product on about 400 patients and wants to know if a letter explaining the affects it could have on the tests.She is trying to figure out if the patients need to be redrawn.She stated that once they figured out they were expired, they threw them away so they do not have any to return for investigation.The lot number is 9304042.She wasn't sure when they noticed they were expired.".

Event Description

It was reported the bd vacutainer® sst¿ blood collection tube was used after the expiration date.The following information was provided by the initial reporter the customer stated: the tubes are expired.Customer stated they used expired product on about 400 patients and wants to know if a letter explaining the affects it could have on the tests.She is trying to figure out if the patients need to be redrawn.She stated that once they figured out they were expired, they threw them away so they do not have any to return for investigation.The lot number is 9304042.She wasn't sure when they noticed they were expired.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for evaluation.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.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER SST BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 11109047
• MDR Text Key: 226246486
• Report Number: 1024879-2020-00979
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679886
• UDI-Public: 50382903679886
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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: Other
• Device Expiration Date: 10/31/2020
• Device Model Number: 367988
• Device Catalogue Number: 367988
• Device Lot Number: 9304042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1