MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367729
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the manufacturing records was completed for the incident lot number and no issues were identified.
Event or Problem Description
It was reported that bd vacutainer® sodium fluoride: 30mg blood collection tubes were having issues with hemolysis.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7557505
• Report Number: 1917413-2018-01487
• Device Sequence Number: 16463104
• Product Code: JKA
• UDI-Device Identifier: 50382903677295
• UDI-Public: 50382903677295
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• 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
• Report Date (Section B): 05/08/2018

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: 09/30/2016
• Device Catalogue Number: 367729
• Device Lot Number: 5064718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2015
• Initial Report FDA Received Date: 05/31/2018
• 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