MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

Catalog Number	367352
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that before use a bd vacutainer® plus plastic sst tube.Gold bd hemogard¿ closure was found with ¿a very sharp plastic protrusion at one side of the vacutainer base, where we anchor the fingers when pushing the tube.¿ there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Bd received a sample from the customer facility for investigation.The sample was evaluated and the customer's indicated failure mode for a protrusion of the molded plastic (flash) on the holder with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Based on evaluation of the customer sample, the customer¿s indicated failure mode for a protrusion of the molded plastic (flash) on the holder with the incident lot was observed.Based on the investigation, the most likely root cause was determined to be related to a manufacturing molding defect issue.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7363279
• Report Number: 1024879-2018-00097
• Device Sequence Number: 10780619
• Product Code: JKA
• UDI-Device Identifier: 50382903673525
• UDI-Public: 50382903673525
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: Phlebotomist
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 367352
• Device Lot Number: 7320729
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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