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 03/30/2023

Event Type  malfunction  

Event Description

It was reported before using the bd vacutainer® k2 edta (k2e) plus blood collection tube the lid/cap was broken.The following information was provided by the initial reporter.The customer stated: "the cap was found to be damaged before usage.".

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 before using the bd vacutainer® k2 edta (k2e) plus blood collection tube the lid/cap was broken.The following information was provided by the initial reporter.The customer stated: "the cap was found to be damaged before usage.".

Manufacturer Narrative

H.6.Investigation summary:bd had received samples; however, [4] photos were provided for investigation.Evaluation of the photographs attached indicated one of the returned samples was cracked from the base of the cap to halfway to the top of the cap.Bd japan received actual samples and confirmed the defect.100 retained samples were visually inspected and no defects were found.Bd was able to duplicate or confirm the customer¿s indicated failure mode based on the photographs attached.Bd was not able to identify a root cause for the indicated failure mode.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode [damaged cap].H3 other text : see h.10.

Event Description

It was reported before using the bd vacutainer® k2 edta (k2e) plus blood collection tube the lid/cap was broken.The following information was provided by the initial reporter.The customer stated: "the cap was found to be damaged before usage.".

Manufacturer Narrative

H.6.Investigation summary: bd had received [5] samples and [4] photos were provided for investigation.Evaluation of the returned samples and photographs attached indicated one of the 5 samples was cracked from the base of the cap to halfway to the top of the cap.100 retained samples were visually inspected and no defects were found.Bd was able to duplicate or confirm the customer¿s indicated failure mode based on the returned samples and photographs attached.Bd was not able to identify a root cause for the indicated failure mode.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode [damaged cap].

• 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 ; 8448235433
• MDR Report Key: 16777582
• MDR Text Key: 313938929
• Report Number: 9617032-2023-00455
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903666435
• UDI-Public: 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,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: 366643
• Device Catalogue Number: 366643
• Device Lot Number: 2189042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• 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