MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 363095

Device Problems Filling Problem (1233); Volume Accuracy Problem (1675)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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® 9nc 0.109m plus blood collection tubes had been having overfill and underfill with their tubes.The following information was provided by the initial reporter.The customer stated: over & underfills - customer suspects vacuum 15% of bottles are showing up in the lab as over or under filled.Staff suspect the vacuum.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 20 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill or overfill as all samples met specifications.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 is unable to be confirmed for the indicated failure modes underfill and overfill.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported when using the bd vacutainer® 9nc 0.109m plus blood collection tubes had been having overfill and underfill with their tubes.The following information was provided by the initial reporter.The customer stated: over & underfills - customer suspects vacuum 15% of bottles are showing up in the lab as over or under filled.Staff suspect the vacuum.

• Brand Name: BD VACUTAINER® 9NC 0.109M 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18103770
• MDR Text Key: 327755801
• Report Number: 9617032-2023-01620
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630955
• UDI-Public: (01)50382903630955
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013971
• 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: 11/15/2023

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: 05/31/2024
• Device Catalogue Number: 363095
• Device Lot Number: 3247744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2023
• 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