MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® SODIUM FLUORIDE: 3 MG NA2 EDTA: 6 MG BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	367587
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to use of the bd vacutainer® sodium fluoride: 3 mg na2 edta: 6 mg blood collection tubes, twenty (20) tubes were observed to be missing additive.There were no health impact or consequences reported.
Event or Problem Description
It was reported that prior to use of the bd vacutainer® sodium fluoride: 3 mg na2 edta: 6 mg blood collection tubes, twenty (20) tubes were observed to be missing additive.There were no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 12-dec-2024.Investigation summary: bd received twenty (20) samples and one (1) photo for investigation.The photo was reviewed and the indicated failure mode for missing additive was observed.Additionally, the customer samples were evaluated by visual examination and the issue of missing additive was observed.Retention samples were evaluated by visual examination and the issue of missing additive was not observed.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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of missing additive.Bd was not able to identify a root cause for the 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® SODIUM FLUORIDE: 3 MG NA2 EDTA: 6 MG BLOOD COLLECTION TUBES
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20882416
• Report Number: 1917413-2024-01180
• Device Sequence Number: 8710414
• Product Code: JKA
• UDI-Device Identifier: 30382903675877
• UDI-Public: (01)30382903675877(11)231016(17)250228(10)3289211
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K231237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 02/28/2025
• Device Catalogue Number: 367587
• Device Lot Number: 3289211
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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