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 tubes break during use with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter: (1 of 2 complaints) the blue top tubes are breaking in the pneumatic tube system and spilling blood all over other specimens and within the bag.Additionally, on 2020-02-28 the bd sales consultant provided the following additional information: 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 tubes break during use with a bd vacutainer® buffered sodium citrate (9nc) blood collection tubes.The following information was provided by the initial reporter: (1 of 2 complaints).The blue top tubes are breaking in the pneumatic tube system and spilling blood all over other specimens and within the bag.Additionally, on (b)(6) 2020 the bd sales consultant provided the following additional information: 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 : bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for glass breakage with the incident lot was observed.Additionally, evaluation of the customer samples was performed and glass breakage was not 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.

• 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: 9835303
• Report Number: 1917413-2020-00278
• Device Sequence Number: 3435244
• 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): 04/22/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• 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: 04/22/2020
• 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
• Patient Age: 58 YR