MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367862

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It has been reported that the bd vacutainer® k2 edta (k2e) plus blood collection tube has been used after the expiration date.No patient impact was reported.The following has been provided by the initial reporter: customer is reporting tube was used one week past expiration.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from customer in support of this complaint from catalog 367862, lot number is unknown.The retentions could not be inspected as the lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.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 identification of emerging trends.

Event Description

It has been reported that the bd vacutainer® k2 edta (k2e) plus blood collection tube has been used after the expiration date.No patient impact was reported.The following has been provided by the initial reporter: customer is reporting tube was used one week past expiration.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18209979
• MDR Text Key: 329023510
• Report Number: 1917413-2023-01179
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678624
• UDI-Public: (01)00382903678624
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367862
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• 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