MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367861

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/28/2022

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 vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced sterility problems.The following information was provided by the initial reporter.The customer stated: it was reported that tubes are damaged inside of damaged box.Customer began to break down a shipment of tubes and noticed damaged product in the middle of the shipment.Pictures attached.

Manufacturer Narrative

H.6.Investigation: bd received 2 photos from the customer in support of this complaint.A visual examination of the photos was performed and revealed damage to the case of product.The product does not leave the manufacturing site in this condition.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.The exact cause of the customer's failure mode could not be determined.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.

Event Description

It was reported when using the bd vacutainer® k2 edta (k2e) 7.2mg blood collection tubes, the device experienced sterility problems.The following information was provided by the initial reporter.The customer stated: it was reported that tubes are damaged inside of damaged box.Customer began to break down a shipment of tubes and noticed damaged product in the middle of the shipment.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
• 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: 14058875
• MDR Text Key: 288988755
• Report Number: 1917413-2022-00180
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903678617
• UDI-Public: 00382903678617
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 367861
• Device Lot Number: 2018855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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