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

Model Number	367729
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during use it was discovered that the vacutainer was cracked with a bd vacutainer® sodium fluoride: 30mg blood collection tubes.The following information was by the initial reporter: (2 of 2 complaints) it is reported customer experienced a crack lip on vacutainer.
Event or Problem Description
It was reported that during use it was discovered that the vacutainer was cracked with a bd vacutainer® sodium fluoride: 30mg blood collection tubes.The following information was by the initial reporter: (2 of 2 complaints) it is reported customer experienced a crack lip on vacutainer.
Additional Manufacturer Narrative
H.6.Investigation summary : bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for lipout 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.H3 other text : see section h.10.

• Brand Name: BD VACUTAINER® SODIUM FLUORIDE: 30MG BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9642749
• Report Number: 1917413-2020-00046
• Device Sequence Number: 2516911
• Product Code: JKA
• UDI-Device Identifier: 50382903677295
• UDI-Public: 50382903677295
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 02/28/2021
• Device Model Number: 367729
• Device Catalogue Number: 367729
• Device Lot Number: 9241024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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