MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	362760
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® cpt¿ cell preparation tube with sodium citrate foreign matter was found within the tube prior to use.No health impact or consequence reported.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes d9: returned to manufacturer on: 16-jan-2024 h.6.Investigation summary: bd received 1 returned sample and 4 photos from the customer for investigation.The indicated failure mode of foreign matter was not observed.The tube does contain floating strands in the liquid density media at the bottom of the tube.Per the specification, floating translucent or reddish-brown strands may appear in the ldm layer of the tube.These are composed of the constituents of the tube and are not considered foreign material.In addition, 40 retentions were visually inspected with no issues being identified.Device history record review of reported incident lot determined all product release requirements were met.There were no related quality issues during product manufacture.This complaint has not been confirmed for foreign matter.Bd was unable to identify a root cause for indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer® cpt¿ cell preparation tube with sodium citrate foreign matter was found within the tube prior to use.No health impact or consequence reported.

• Brand Name: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18485938
• Report Number: 1917413-2023-01331
• Device Sequence Number: 15741694
• Product Code: JKA
• UDI-Device Identifier: 50382903627603
• UDI-Public: (01)50382903627603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: Other
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 362760
• Device Lot Number: 3172076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown