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	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that when using the bd vacutainer® cpt¿ cell preparation tube with sodium citrate tubes, the tubes provide a poor return of blood during blood collection.There was no report of patient impact.
Event or Problem Description
It was reported that when using the bd vacutainer® cpt¿ cell preparation tube with sodium citrate tubes, the tubes provide a poor return of blood during blood collection.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields were updated: d9.Device available for evaluation? yes returned to manufacturer on: (b)(6) 2023 h.6.Investigation summary: bd received 10 returned samples and 4 photos for investigation.The 4 photos were reviewed, and the indicated failure mode of underfill was not observed.  the 10 returned customer samples were evaluated by draw-testing, and all tubes were within specification limits.Additionally, 60 production lot in-house retention tubes were visually inspected with no issues identified.Device history record review of reported incident lot determined all product release requirements were met, and there were no related quality issues during product manufacture.This complaint was unable to be confirmed for indicated failure mode of underfill.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.

• 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: 18283944
• Report Number: 1917413-2023-01227
• Device Sequence Number: 20507389
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 01/31/2024
• Device Catalogue Number: 362760
• Device Lot Number: 3024218
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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