MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE; BLOOD COLLECTION TUBE

Catalog Number 367983

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

Results: bd received one sample from the customer facility for investigation.The sample was evaluated by draw testing the tube with water and the customer's indicated failure mode for stopper pull off with the incident lot was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined.

Event Description

It was reported that the stopper fell off of the bd vacutainer® plus plastic sst tube.Gold bd hemogard¿ closure.No injury or medical intervention.

• Brand Name: BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7113119
• MDR Text Key: 95212106
• Report Number: 1024879-2017-01300
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679831
• UDI-Public: 50382903679831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 367983
• Device Lot Number: 5345732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2015
• 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