MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER NO ADDITIVE (Z) PLUS TUBES; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 366408

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

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.(b)(4).

Event Description

It was reported the bd vacutainer® no additive (z) plus tubes experienced stopper pops out of the tube.The following information was provided by the initial reporter.The customer stated the "stoppers are popping off during centrifugation.The caps of these tubes would not stay on during centrifugation.".

Manufacturer Narrative

H.6.Investigation: bd received one-hundred (100) samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for stopper pop-off with the incident lot was 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.Extra lubricant on the stoppers could be a contributor for the loose cap.

Event Description

It was reported the bd vacutainer® no additive (z) plus tubes experienced experienced stopper pops out of the tube.The following information was provided by the initial reporter.The customer stated the "stoppers are popping off during centrifugation.The caps of these tubes would not stay on during centrifugation.".

• Brand Name: BD VACUTAINER NO ADDITIVE (Z) PLUS TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 10936614
• MDR Text Key: 219370995
• Report Number: 1024879-2020-00905
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 366408
• Device Lot Number: 0218172
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1