MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	369714
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
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 breakage occurred after use with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.This occurred on 2 separate occasions, however, the date/time is unknown.The following information was provided by the initial reporter: (2 of 2 complaints) it is reported customer experienced breakage when using vacutainers.Additional information from customer: were the tubes frozen? (no), was there damage upon receipt? (they shattered in the pneumatic tube system after specimen collection) and what was the time and speed of centrifuged? (not centrifuged).
Event or Problem Description
It was reported that breakage occurred after use with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.This occurred on 2 separate occasions, however, the date/time is unknown.The following information was provided by the initial reporter: (2 of 2 complaints) it is reported customer experienced breakage when using vacutainers.Additional information from customer: were the tubes frozen? (no), was there damage upon receipt? (they shattered in the pneumatic tube system after specimen collection) and what was the time and speed of centrifuged? (not centrifuged).
Additional Manufacturer Narrative
H.6.Investigation summary upon evaluation of the customer returned photo, the customer¿s product issue was observed during visual evaluation of the photo at the manufacturing site.No samples were received at the manufacturing site; therefore, the investigation was limited.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.The product.

• Brand Name: BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) 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: 9836590
• Report Number: 1917413-2020-00280
• Device Sequence Number: 11621750
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: 01/31/2021
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 9184008
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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