MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT

Catalog Number	364956
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Results - two samples were received from the customer, each showing the reported defect.A review of the device history record revealed no irregularities during the manufacture of the reported lot #5212996.Conclusion - the mechanical tech was interviewed.He states the most like case is a jam in the airway that transfer the cups over.In order to clear the jam, technicians turn up the air.Doing so will cause the cups to hit the stop and cause cracking.
Event or Problem Description
It was reported that the 16mm x 100mm x 8ml bd vacutainer® plus plastic collection kit cups have cracks and/or holes in them.No injury or medical intervention reported.

• Brand Name: 16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT
• Common Device Name: COLLECTION KIT
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7059082
• Report Number: 1917413-2017-00221
• Device Sequence Number: 13682137
• Product Code: KDT
• UDI-Device Identifier: 00382903649464
• UDI-Public: 00382903649464
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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
• Operator of Device: Other
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 364956
• Device Lot Number: 5212996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2016
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other