MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 366643

Device Problem Break (1069)

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

Event Date 12/13/2022

Event Type  malfunction  

Event Description

It was reported that one of the bd vacutainer® k2 edta (k2e) plus blood collection tubes had a damaged cap.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the cap was damaged.

Manufacturer Narrative

Investigation summary: bd did receive 3 photographs from the customer in support of this complaint.Evaluation of the attached photographs shows evidence of damaged cap.100 retained samples were visually checked and no defects were found.Bd was able to duplicate or confirm the customer¿s indicated failure mode with the photos provided, however retained samples were satisfactory.Bd was able to duplicate or confirm the customer¿s indicated failure mode with the photos provided, however retained samples were satisfactory.A complaint history review was conducted and only the current complaint was found relating to the incident lot number: 2038961 the ¿as reported¿ defect code.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 16126327
• MDR Text Key: 308649150
• Report Number: 9617032-2023-00010
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903666435
• UDI-Public: (01)50382903666435
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/04/2023

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: 02/28/2023
• Device Model Number: 366643
• Device Catalogue Number: 366643
• Device Lot Number: 2038961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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