MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 13X100 MM 6.0 ML BD VACUTAINER® PLUS PLASTIC TUBE SERUM TUBE.; BLOOD COLLECTION TUBE.

Catalog Number	368660
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: a review of the device history revealed no related quality notifications.The returned sample was drawn and evaluated for stopper pull out.The tubes did not test out of specification for draw.There was no stopper pull out identified.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers¿ indicated failure mode.
Event or Problem Description
It was reported that for the 13 x 100 mm 6.0 ml bd vacutainer® plus plastic tube serum tube, the stopper was more difficult to pierce and this led to stopper pull out when removing collection device.No serious injury, and no medical intervention.No mucous membrane exposure reported.
Additional Manufacturer Narrative
Correction added to the following fields: mdr owndership tab-crs# (b)(4).B-tab:date of event: (b)(6) 2016.

• Brand Name: 13X100 MM 6.0 ML BD VACUTAINER® PLUS PLASTIC TUBE SERUM TUBE.
• Common Device Name: BLOOD COLLECTION TUBE.
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7008129
• Report Number: 1917413-2017-00157
• Device Sequence Number: 13826920
• Product Code: JKA
• UDI-Device Identifier: 00382903686605
• UDI-Public: 00382903686605
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K960250
• 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,Followup
• Report Date (Section B): 01/12/2018

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
• Operator of Device: Other
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 368660
• Device Lot Number: 5210523
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2016
• Supplement Date Received by Manufacturer: 01/15/2016
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/15/2018
• 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