MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER 9NC 0.109M PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 363095

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 20 bd vacutainer® 9nc 0.109m plus blood collection tubes underfilled.The following information was provided by the initial reporter: "when using the tube,it was found that the tube did not draw enough.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, 20 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to underfill/ no draw 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 that 20 bd vacutainer® 9nc 0.109m plus blood collection tubes underfilled.The following information was provided by the initial reporter: "when using the tube,it was found that the tube did not draw enough.".

• Brand Name: BD VACUTAINER 9NC 0.109M PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11103354
• MDR Text Key: 224688048
• Report Number: 1917413-2020-01274
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Model Number: 363095
• Device Catalogue Number: 363095
• Device Lot Number: 0122039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1