MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367989

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® sst¿ blood collection tubes were deformed.This was discovered after use.The following information was provided by the initial reporter: the tube was deformed badly.

Manufacturer Narrative

H.6.Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for lipout with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.

Event Description

It was reported that bd vacutainer® sst¿ blood collection tubes were deformed.This was discovered after use.The following information was provided by the initial reporter: the tube was deformed badly.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9537015
• MDR Text Key: 181622856
• Report Number: 1024879-2019-02211
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679893
• UDI-Public: 50382903679893
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Model Number: 367989
• Device Catalogue Number: 367989
• Device Lot Number: 9095591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other