MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VACUTAINER® K2 EDTA 3.6MG; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367227

Device Problem Component Misassembled (4004)

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

Event Date 09/22/2022

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 3.6mg, the device experienced stopper creep out/loose closure, and a broken lid/cap.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: when opened the package, it was found that the shield had size deviation issue.Patients and users were not affected.

Event Description

It was reported when using the bd vacutainer® k2 edta 3.6mg, the device experienced stopper creep out/loose closure, and a broken lid/cap.This event occurred 6 times.The following information was provided by the initial reporter.The customer stated: when opened the package, it was found that the shield had size deviation issue.Patients and users were not affected.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for improper assembly was observed.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of improper assembly was not observed.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 improper assembly.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® K2 EDTA 3.6MG
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15554915
• MDR Text Key: 303316234
• Report Number: 3006948883-2022-00181
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 367227
• Device Lot Number: 1362763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2021
• 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