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	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2020
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.(b)(4).
Event or Problem Description
It was reported that the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes were found with missing additive.This event occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that the tubes are missing the additive causing the tube to clotting.She informed me that they are having an issue with their sodium citrate tube (cat 369714).There is no liquid additive in the tube and specimens are clotting.
Event or Problem Description
It was reported that the bd vacutainer® buffered sodium citrate (9nc) blood collection tubes were found with missing additive.This event occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that the tubes are missing the additive causing the tube to clotting.She informed me that they are having an issue with their sodium citrate tube (cat 369714).There is no liquid additive in the tube and specimens are clotting.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, 5 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to clotting due to missing additive as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality non-conformances during manufacturing of the product.Bd was unable to determine the root cause of the customer's issue.

• 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: 11142227
• Report Number: 1917413-2021-00008
• Device Sequence Number: 16355583
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 369714
• Device Catalogue Number: 369714
• Device Lot Number: 0100319
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1