MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365992
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd microtainer® tubes with fe (sodium fluoride/disodium edta), an unspecified amount of tubes were clotting when animal heart blood was collected via a syringe and then transferred into the microtainer tubes.There was no impact or consequences reported.
Additional Manufacturer Narrative
Unknown lot number medical device expiration date: unknown.Device manufacture date: unknown.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 when using the bd microtainer® tubes with fe (sodium fluoride/disodium edta), an unspecified amount of tubes were clotting when animal heart blood was collected via a syringe and then transferred into the microtainer tubes.There was no impact or consequences reported.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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.Complaints for sample quality are under statistical control for the month of march 2024.If complaints for sample quality reach an action level, additional testing may be required.Bd quality will continue to monitor sample quality complaints.H3 other text : see h.10.

• Brand Name: BD MICROTAINER® TUBES WITH FE (SODIUM FLUORIDE/DISODIUM EDTA)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19150129
• Report Number: 2618282-2024-00025
• Device Sequence Number: 13116714
• Product Code: JKA
• UDI-Device Identifier: 30382903659921
• UDI-Public: (01)30382903659921
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/24/2024

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 Catalogue Number: 365992
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/21/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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