MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES; 50382903688611

Model Number 368861

Device Problem Component Missing (2306)

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

Event Date 10/24/2022

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® k2e (edta) 7.2mg plus blood collection tubes it did not have a rubber septum, therefore it was unusable.The following information was provided by the initial reporter.The customer stated: ¿the vacutainer tubes did not have a rubber septum therefore it was unusable.Another tuber had to used.".

Event Description

It was reported when using the bd vacutainer® k2e (edta) 7.2mg plus blood collection tubes it did not have a rubber septum, therefore it was unusable.The following information was provided by the initial reporter.The customer stated: ¿the vacutainer tubes did not have a rubber septum therefore it was unusable.Another tuber had to used.".

Manufacturer Narrative

H.6.Investigation summary: bd received 2 photographs from the customer in support of this complaint.An evaluation of the photos was performed and revealed the cap with the missing stopper.Additionally, 100 retained samples from the bd inventory were visually inspected, and there were no issues relating to missing stoppers.Bd was able to confirm the customer¿s indicated failure mode with the photos provided.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES
• Type of Device: 50382903688611
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15737943
• MDR Text Key: 307184781
• Report Number: 9617032-2022-01101
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903688611
• UDI-Public: 50382903688611
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 11/08/2022

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: 09/30/2023
• Device Model Number: 368861
• Device Catalogue Number: 368861
• Device Lot Number: 2125071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/08/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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