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

Catalog Number	366593
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is htl.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B3: date of event is unknown.The date received by manufacturer has been used for this field.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 prior to using bd microtainer® contact-activated lancet, the protective cap of an unspecified number of devices comes off exposing needle.No adverse impact was reported regarding the patient or user.
Event or Problem Description
It was reported that prior to using bd microtainer® contact-activated lancet, the protective cap of an unspecified number of devices comes off exposing needle.No adverse impact was reported regarding the patient or user.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d10.Device available for eval- yes.D10.Returned to manufacturer on: 10-mar-2025.H3.Device eval by manufacturer- yes.Investigation summary - bd received 36 samples and 7 photos for investigation.The photos were reviewed and the indicated failure modes for cracked, fm - unknown, loose cap, and molding defects were observed.Retention samples were evaluated by visual examination and the issue of fm - unknown was observed on 3 lancets.Additionally, the customer samples were evaluated by visual examination and the following was observed.-one lancet with cracked shield, -7 lancets with scratches and damages, -one lancet with scratches and removable dirt¿s, -6 lancets with removable dirt¿s, -3 lancets dirt¿s on the components, -1 lancet with a mechanically damaged tab cap and incorrectly assembled, after unscrewing the cap an element of the needle cover is visible inside, -9 lancets with not assembled tab cap, -2 no activated lancet without protective cap.-1 lancet with mechanical damage on the rear cap, on the lower edge.-5 complete lancets with mechanically damaged lower edge of the shield there is raw needle visible in all lancets.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 cracked, fm - unknown, loose cap, and molding defects.The indicated failure modes were attributed to the supplier.The supplier has initiated further root cause investigation relating to the issues of cracked and loose cap through corrective and preventive actions.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 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21620855
• Report Number: 2243072-2025-00301
• Device Sequence Number: 15162882
• 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: E4C18B7
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/28/2025; Not provided
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/23/2025; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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