MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE; BLOOD COLLECTION TUBE

Catalog Number 367953

Device Problem Defective Device (2588)

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

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was not returned for evaluation.The customer provided one photograph confirming the reported defect.A review of the device history record was performed for lot #: 6011688 for this incident.Conclusion: an absolute root cause for this incident cannot be determined as there was insufficient evidence to categorize the defect.

Event Description

It was reported that the stoppers on six of the 16 x 100 mm x 8.5 ml bd vacutainer® sst ii plus plastic serum tubes were defective.A photograph returned showed the tops of the six tubes had cracks in the center of their stoppers.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7078009
• MDR Text Key: 94247249
• Report Number: 9617032-2017-00252
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679539
• UDI-Public: 00382903679539
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: BK050036
• 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
• Report Date: 11/01/2017

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: 06/30/2017
• Device Catalogue Number: 367953
• Device Lot Number: 6011688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 12/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• 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