MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 5.4MG; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367856

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported while using bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes usage after expiration date.This occurred 15 times.The following information was provided by the initial reporter: customer inquired if patients needs to be redrawn as samples were taken using expired tubues.

Event Description

It was reported while using bd vacutainer® k2 edta (k2e) 5.4mg blood collection tubes usage after expiration date.This occurred 15 times.The following information was provided by the initial reporter: customer inquired if patients needs to be redrawn as samples were taken using expired tubes.

Manufacturer Narrative

H.6.Investigation summary: no samples or photos were returned by the customer in support of this complaint.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.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4MG
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15346007
• MDR Text Key: 299169391
• Report Number: 1917413-2022-00532
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678568
• UDI-Public: 50382903678568
• 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: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367856
• Device Catalogue Number: 367856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• 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