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

Model Number 367856

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported before use of the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tube there was label lift off/partial peel off.This event affected 200 devices.The following information was provided by the initial reporter and translated to english.The customer stated: after checking the purple tube in the warehouse, it was found that there were two sheets of purple tube (100 pcs/board) with upturned labels.The product was not sent out for use.".

Manufacturer Narrative

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

Manufacturer Narrative

H.6.Investigation summary: bd received 2 photos from the customer in support of this complaint.A visual evaluation of the photos was conducted and the issue of label lift was observed.Additionally, 100 retention samples were inspected with no label lift being identified.Bd was able to confirm the customer¿s indicated failure mode because the defect was observed in the customer photos; however, was not observed in the retention samples.The exact cause for 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 before use of the bd vacutainer® k2 edta (k2e) 5.4mg blood collection tube there was label lift off/partial peel off.This event affected 200 devices.The following information was provided by the initial reporter and translated to english.The customer stated: after checking the purple tube in the warehouse, it was found that there were two sheets of purple tube (100 pcs/board) with upturned labels.The product was not sent out for use.".

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 5.4MG 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15473425
• MDR Text Key: 306086356
• Report Number: 1917413-2022-00600
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678568
• UDI-Public: 50382903678568
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/12/2022

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 Expiration Date: 05/31/2023
• Device Model Number: 367856
• Device Catalogue Number: 367856
• Device Lot Number: 2018849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/17/2022
• 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