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

Catalog Number	367352
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation - based on the investigation, the most likely root cause has been identified for severed tubing, and capa 50210 has been initiated to document the investigation and root cause analysis of the reported incidents.Refer to the referenced capa for related corrective and preventive actions.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set with pre-attached holder had severed tubing, which could lead to a leak.No injury or medical intervention reported.
Additional Manufacturer Narrative
Additional information: i: device history record review: a review of the device history record was completed for this batch.Product was manufactured at the bd sumter site in july 2016.Product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.All inspections were in compliance with requirements.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set with pre-attached holder had severed tubing, which could lead to a leak.No injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7438045
• Report Number: 1024879-2018-00518
• Device Sequence Number: 1030638
• Product Code: FPA
• UDI-Device Identifier: 50382903673525
• UDI-Public: 50382903673525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011984
• 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): 09/10/2018

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: 07/31/2018
• Device Catalogue Number: 367352
• Device Lot Number: 6202832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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