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

Model Number 367988

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It has been reported that the bd vacutainer® sst¿ blood collection tube has been found used after the expiration date.The following has been provided by the initial reporter: it was reported that tubes were used past the expiration date.

Manufacturer Narrative

Investigation summary: catalog number: 367988.Batch number: 1006143.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.As no customer samples or photos were received the scope of this investigation is limited.No root cause from manufacturing was identified as a contributor as there were no photos or samples provided.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.Bd makes no claims on expired product.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for monitoring of current trends.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13389160
• MDR Text Key: 285846672
• Report Number: 1024879-2022-00039
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679886
• UDI-Public: 50382903679886
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 367988
• Device Catalogue Number: 367988
• Device Lot Number: 1006143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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