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

Model Number 363095

Device Problem Overfill (2404)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported the bd vacutainer® 9nc 0.109m plus blood collection tubes experienced overfill.This event occurred 10 times.The following information was provided by the initial reporter: translated to english.The customer stated the "coag tubes were overfilling so the samples had to be rejected.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to 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 non-conformances during manufacturing of the product.

Event Description

It was reported the bd vacutainer® 9nc 0.109m plus blood collection tubes experienced overfill.This event occurred 10 times.The following information was provided by the initial reporter: translated to english.The customer stated the "coag tubes were overfilling so the samples had to be rejected.".

• 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
• MDR Report Key: 11005101
• MDR Text Key: 228212322
• Report Number: 9617032-2020-01038
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903630955
• UDI-Public: 50382903630955
• Combination Product (y/n): N
• PMA/PMN Number: K013971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Model Number: 363095
• Device Catalogue Number: 363095
• Device Lot Number: 0272207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1