MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 366643

Device Problems Expiration Date Error (2528); Inaccurate Information (4051)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 2153654, d4.Medical device expiration date: 30-june-2023, h4.Device manufacture date: 02-june-2022.D4.Medical device lot#: 3020668, d4.Medical device expiration date: 31-jan-2024, h4.Device manufacture date: 20-jan-2023.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® k2 edta (k2e) plus blood collection tubes expiration and label discrepancy on two different lots; lot # 3020668; exp 1/31/24; tubes - lot # 2153654tube exp 6/30/23.No patient impact was reported.The following information was provided by the initial reporter: discrepant lot and expiration date on packing and tubes discrepant lot and expiration date of product.The product packing shows a different lot # and expiration date than what is printed on the tubes; pack - lot # 3020668 exp 1/31/24; tubes - lot # 2153654 tube exp 6/30/23.

Manufacturer Narrative

H.6.Investigation summary: material #: 366643 lot/batch #: 2153654, 3020668 bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for incorrect label on the shelf pack was observed.The shelf pack label showed "lot 3020668 exp: 01/2024" and the unit label of the tube showed, "lot 2153654 exp: 06/2023".Additionally, retention shelf packs from bd inventory of both lots were evaluated by visual examination, and both had correct labeling of the shelf pack.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.This complaint has been confirmed for the indicated failure mode of incorrect labeling and expired product.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that bd vacutainer® k2 edta (k2e) plus blood collection tubes expiration and label discrepancy on two different lots lot # 3020668 exp 1/31/24; tubes - lot # 2153654tube exp 6/30/23.No patient impact was reported.The following information was provided by the initial reporter: discrepant lot and expiration date on packing and tubes discrepant lot and expiration date of product.The product packing shows a different lot # and expiration date than what is printed on the tubes; pack - lot # 3020668 exp 1/31/24; tubes - lot # 2153654tube exp 6/30/23.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 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
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17674495
• MDR Text Key: 323197967
• Report Number: 9617032-2023-01180
• Device Sequence Number: 1
• Product Code: JKA
• 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,Followup
• Report Date: 09/25/2023

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 Catalogue Number: 366643
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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