MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE; BLOOD COLLECTION TUBE.

Catalog Number 362799

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

Results: a review of the device history record was completed for lot 5154675.No sample was sent.A photo confirms the plastic on the end of the tube.Conclusion: this defect is referred to as gate stub.It occurs when the valve gate for the part stays in the open position and this creates the extra plastic.Due to the severity and occurrence rate there will not be a capa opened at this time.We will monitor these defects for tracking and trending purposes.

Event Description

It was reported that bd vacutainer® ppt¿ plasma preparation tube had some excess plastic on the bottom that prevented the sample from being processed on the equipment.No mucous membrane exposure.No serious injury, no medical interventions.

Manufacturer Narrative

The initial mdr was submitted with the incorrect device type code.The correct device type code is jka.

• Brand Name: BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE
• Type of Device: BLOOD COLLECTION TUBE.
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7058809
• MDR Text Key: 93472645
• Report Number: 1917413-2017-00135
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903627993
• UDI-Public: 50382903627993
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K972075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 362799
• Device Lot Number: 5154675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 03/15/2016
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other