MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 366566

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2020

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.

Event Description

It was reported that prior to use foreign matter that looks "moldy" was discover on shied with a bd vacutainer® sst¿ ii advance plus blood collection tubes.The following information was provided by the initial reporter, translated from (b)(6) to english: before use, the customer found 1ea tube shield has fm on it, it looks moldy.

Event Description

It was reported that prior to use foreign matter that looks "moldy" was discover on shied with a bd vacutainer® sst¿ ii advance plus blood collection tubes.The following information was provided by the initial reporter, translated from chinese to english: before use, the customer found 1ea tube shield has fm on it, it looks moldy.

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 3 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for foreign matter on the shield 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 non-conformances during manufacturing of the product.

• Brand Name: BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 10097369
• MDR Text Key: 193053718
• Report Number: 9617032-2020-00444
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: BK050036
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 366566
• Device Lot Number: 9227678
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other