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 10/27/2020

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 had the stopper pop out of the tube.The following information was provided by the initial reporter: translated to english.The customer stated : caps are popping off during transport and spilling (tubes are half to 3/4 full).Sometimes the plastic part of the cap separates from the rubber stopper.Note: these tubes are used for aliquots so the caps are not staying on while reapplied.The non-additive tube cap goes back on but is super easy to pull off, with very little resistance.The original stoppers are popping off or coming apart (rubber stopper and clear cap separating).".

Manufacturer Narrative

H6: investigation summary bd received ten (10) samples for investigation.The samples were evaluated by functional testing and the indicated failure mode of stopper pop-off with the incident lot was observed.Bd was unable to determine the root cause of the customer's issue.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported the bd vacutainer® no additive (z) plus tubes had the stopper pop out of the tube.The following information was provided by the initial reporter: translated to english.The customer stated :caps are popping off during transport and spilling (tubes are half to 3/4 full).Sometimes the plastic part of the cap separates from the rubber stopper.Note: these tubes are used for aliquots so the caps are not staying on while reapplied.The non-additive tube cap goes back on but is super easy to pull off, with very little resistance.The original stoppers are popping off or coming apart (rubber stopper and clear cap separating).".

• 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: 10857712
• MDR Text Key: 219570733
• Report Number: 1024879-2020-00852
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1