MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® CONTACT-ACTIVATED LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	366593
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.Medical device lot #: d4a49b7.D4.Medical device expiration date: 15-02-2028.H4.Device manufacture date: 13-06-2023.E.1 initial reporter city: kaisei town, ashigarakami district.H.3.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 that while using bd microtainer® contact-activated lancet that multiple defects were identified.The customer discovered lancets with foreign matter, assembly defects, molding defects, cracks, and discoloration.The defects were discovered prior to use, and no impact to patients was reported.
Event or Problem Description
It was reported that while using bd microtainer® contact-activated lancet that multiple defects were identified.The customer discovered lancets with foreign matter, assembly defects, molding defects, cracks, and discoloration.The defects were discovered prior to use, and no impact to patients was reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes d.9:device eval by manufacturer? yes d9: returned to manufacturer on: 2024-april- 5th h.6 investigation summary material #: 366593 lot/batch #: c4p61m4 & d4a49b7 bd received 200 samples for investigation.The samples were evaluated by visual examination and the following defects were observed: from lot number c4p61m4 there were 4 lancets with discolored housing, 1 lancet with cracked housing, 4 lancets with molding defects on their housing, 2 lancets with housing separation, and 6 lancets with foreign matter.From lot number d4a49b7 there were 2 lancets with discolored housing, 2 lancets with housing separation, and 7 lancets with foreign matter.Additionally, retention samples of each reported lot number from bd inventory were evaluated by visual examination and upon completion no defects or failures were 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 modes discolored housing, cracked housing, molding defect, housing separation, and foreign matter.The indicated failure modes were attributed to the supplier.The supplier has initiated further root cause investigation relating to the issues of foreign matter, cracked housing, housing separation, molding defects, and cracked shield through corrective and preventive actions.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD MICROTAINER® CONTACT-ACTIVATED LANCET
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18990432
• Report Number: 2243072-2024-00453
• Device Sequence Number: 11512600
• Product Code: FMK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2026

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: 366593
• Device Lot Number: C4P61M4
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/17/2024; Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/07/2024; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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