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

Model Number 367986

Device Problem Expiration Date Error (2528)

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

Event Date 03/08/2023

Event Type  malfunction  

Event Description

It was reported that prior to use with bd vacutainer® sst¿ blood collection tubes the tubes in the tray had an expired expiration.The label on the tray had a different expiration date that was not expired.The following information was provided by the initial reporter, translated from chinese to english: stage: unopened for use, when checking the outer packaging.Defect: expired products are relabeled for sale.Quantity: 100 pieces.Impact: no impact on patients and users.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6.Bd received 1 customer returned shelf pack samples and 3 photos for investigation.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.A complaint history was performed, and this was the only complaint received on this batch for the reported defect.After evaluation of the photo, it was shown that there were multiple shelf labels on the package.After inspecting the received customer sample, bd was able to remove the top label that included the incorrect information and found that the correct label (that included batch# 2069383) and the distribution center translated label that is placed on the package, which also included the correct information, was under the incorrect label (which included batch# 2236548).Additionally, the larger translated label on the back of the shelf pack presents the same information that was within the shelf pack (batch# 2069383).Additionally, per our procedures during a batch change all labels are removed from the line and placed into the proper waste container.The next batch is not started until the line clearance is completely finished.Therefore, bd is unable to confirm the customer reported defect as this occurred outside of the manufacturing site.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.H3 other text : see h10.

Event Description

It was reported that prior to use with bd vacutainer® sst¿ blood collection tubes the tubes in the tray had an expired expiration.The label on the tray had a different expiration date that was not expired.The following information was provided by the initial reporter, translated from chinese to english: stage: unopened for use, when checking the outer packaging defect: expired products are relabeled for sale quantity: 100 pieces impact: no impact on patients and users.

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16641015
• MDR Text Key: 312422764
• Report Number: 1024879-2023-00178
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679862
• UDI-Public: (01)50382903679862
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: 2069383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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