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 Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2020

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 that foreign matter "yellow residue" was discovered prior to use with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: it was reported that there was yellow residue on the product.

Event Description

It was reported that foreign matter "yellow residue" was discovered prior to use with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: it was reported that there was yellow residue on the product.

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but photos were provided by the customer for investigation.Two (2) photos were received for analysis.The photos verify the reported issue of fm.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.

• 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: 10514809
• MDR Text Key: 207319352
• Report Number: 1024879-2020-00632
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 366408
• Device Lot Number: 0093568
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other