MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® PLASTIC PST¿ LITHIUM HEPARIN 8.0 ML DRAW, 16X100MM TUBE; BLOOD COLLECTION TUBE

Catalog Number 367964

Device Problems Detachment Of Device Component (1104); Compatibility Problem (2960)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot #5154692.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that a plastic pst tube for plasma separation lithium heparin 8.0 ml draw, 16x100mm caps kept falling off.The caps were reported to be too small and the tubes did not vacuum.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PLASTIC PST¿ LITHIUM HEPARIN 8.0 ML DRAW, 16X100MM 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: 7083343
• MDR Text Key: 94813446
• Report Number: 1917413-2017-00369
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679645
• UDI-Public: 00382903679645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 367964
• Device Lot Number: 5154692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• 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