MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	367323
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for 73263 with the incident lot was observed.Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set was labeled incorrectly as the product that was received was a push button device without a vacutainer.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7464349
• Report Number: 1710034-2018-00464
• Device Sequence Number: 16186079
• Product Code: JKA
• UDI-Device Identifier: 50382903673235
• UDI-Public: 50382903673235
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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: 10/31/2018
• Device Catalogue Number: 367323
• Device Lot Number: 6295713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2016
• Initial Report FDA Received Date: 04/26/2018
• 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