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 Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 during use the bd vacutainer® sst¿ blood collection tube was used after the expiration date.The following information was provided by the initial reporter: two donor centers recently discovered that they used this tube 30 days after the expiration date and they need documents detailing the stability of the samples.The tubes were stored at controlled room temperature prior to use.Samples have been sent to the laboratory for testing.

Manufacturer Narrative

H.6.Investigation summary: a review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Letter was sent by bd technical service to customer regarding expired material.H3 other text : see h.10.

Event Description

It was reported during use the bd vacutainer® sst¿ blood collection tube was used after the expiration date.The following information was provided by the initial reporter: two donor centers recently discovered that they used this tube 30 days after the expiration date and they need documents detailing the stability of the samples.The tubes were stored at controlled room temperature prior to use.Samples have been sent to the laboratory for testing.

• 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: 10471935
• MDR Text Key: 207147557
• Report Number: 1024879-2020-00612
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Model Number: 367988
• Device Catalogue Number: 367988
• Device Lot Number: 9199571
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other