MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364960
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for label mismatch with the incident lot was observed.The was dhr reviewed and there was a qn for incorrect label.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.
Event or Problem Description
It was reported bd vacutainer® blood collection tubes for microbiological studies has mismatched label information between the box label and the product inside.This was noticed before use and no injury or medical interventions were reported.

• Brand Name: BD VACUTAINER® BLOOD COLLECTION TUBES FOR MICROBIOLOGICAL STUDIES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7427929
• Report Number: 1917413-2018-00771
• Device Sequence Number: 333295
• Product Code: JKA
• UDI-Device Identifier: 50382903649605
• UDI-Public: 50382903649605
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: 04/30/2017
• Device Catalogue Number: 364960
• Device Lot Number: 6090812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Initial Report FDA Received Date: 04/13/2018
• 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