MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD MICROTAINER® MAP MICROTUBE K2 EDTA 1.0 MG; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 363706

Device Problems Leak/Splash (1354); Component Misassembled (4004)

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

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported when using the bd microtainer® map microtube for automated process k2 edta 1.0 mg customer state that the cap is loose and leakage occurred inside the bag during transportation.The following information was provided by the initial reporter.The customer stated: ¿it was reported by the customer that cap is loose and leakage occurred inside of bag during transportation.¿.

Manufacturer Narrative

H.6.Investigation summary: no samples and no photos were returned by the customer in support of this complaint.Therefore, 50 retention samples were visually inspected with no issues being identified.Bd was unable to confirm the customer¿s indicated failure mode based on the investigation completed.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.H3 other text : see h.10.

Event Description

It was reported when using the bd microtainer® map microtube for automated process k2 edta 1.0 mg customer state that the cap is loose and leakage occurred inside the bag during transportation.The following information was provided by the initial reporter.The customer stated: ¿it was reported by the customer that cap is loose and leakage occurred inside of bag during transportation.¿.

• Brand Name: BD MICROTAINER® MAP MICROTUBE K2 EDTA 1.0 MG
• 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: 15538815
• MDR Text Key: 301126637
• Report Number: 1917413-2022-00619
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903637060
• UDI-Public: 50382903637060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093972
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 363706
• Device Catalogue Number: 363706
• Device Lot Number: 1266040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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