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

Model Number 366703

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

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) tubes experienced foreign matter in tube biological and non-biological.This event occurred 35 times.The following information was provided by the initial reporter: translated to english.The customer stated: there were "black spots on tubes.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/23/2021.H.6.Investigation: bd received (35) thirty-five samples and (12) twelve photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for embedded foreign matter with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for embedded foreign matter 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.

Event Description

It was reported the bd vacutainer® no additive (z) tubes experienced foreign matter in tube biological and non-biological.This event occurred 35 times.The following information was provided by the initial reporter: translated to english.The customer stated: there were "black spots on tubes.".

• Brand Name: BD VACUTAINER NO ADDITIVE (Z) TUBES
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11241053
• MDR Text Key: 229111266
• Report Number: 1917413-2021-00049
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: 366703
• Device Catalogue Number: 366703
• Device Lot Number: 9344910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1