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

Catalog Number	366593
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturing site: 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.D4.Medical device lot#: unknown d4.Medical device expiration date: unknown h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H4.Device manufacture date: unknown.
Event or Problem Description
It was reported that prior to using bd microtainer® contact-activated lancet, there were black dots and stains found on the devices.No patient impact reported.
Event or Problem Description
It was reported that prior to using bd microtainer® contact-activated lancet, there were black dots and stains found on the devices.No patient impact reported.
Additional Manufacturer Narrative
The following fields have been updated with additional information.D4.Medical device lot#: c4j68e8 d4.Medical device expiration date: 17-07-2027 h4.Device manufacture date: (b)(6) 2022 d4.Medical device lot#: c4m61k2 d4.Medical device expiration date: 02-10-2027 h4.Device manufacture date: (b)(6) 2022 d4.Medical device lot#: c4p61m4 d4.Medical device expiration date: 22-11-2027 h4.Device manufacture date: (b)(6) 2022 d4.Medical device lot#: c4k28f3 d4.Medical device expiration date: 14-08-2027 h4.Device manufacture date: (b)(6) 2022.
Event or Problem Description
It was reported that prior to using bd microtainer® contact-activated lancet, there were black dots and stains found on the devices.No patient impact 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-february -16.H.6 investigation summary material #: 366593 lot/batch #: c4j68e8, c4k28f3, c4m61k2, c4p61m4 bd received 600 samples (4 from lot c4j68e8, 273 from lot c4k28f3, 242 from lot c4m61k2, and 81 from lot c4p61m4) for investigation.The samples were evaluated by visual examination and the following defects were observed: lot c4k28f3 - 2 lancets with damaged levers, 2 lancets with gaps in their housing, 1 lancet with damaged latches in its rear cap, 8 lancets with foreign matter, and 13 lancets with damaged housing.Lot c4p61m4 - 1 lancet with damaged latches in its rear cap, 3 lancets with discolored shields, 6 lancets with foreign matter, 2 lancets with molding defects on their housing, and 1 lancet with damaged housing.Lot c4p61k2 - 1 lancet that was assembled improperly, 3 lancets with foreign matter, 3 lancets with damaged levers, 7 lancets with damaged housing, and 2 lancets with damaged latches in their rear cap.No defects were observed with the returned samples from lot c4j68e8.Additionally, retention samples from bd inventory were evaluated by visual examination and upon completion the following defects were observed: lot c4j68e8 - 1 lancet with under-molded ribs in its rear cap, 3 lancets with damaged housing, and 1 lancet with foreign matter lot c4k28f3 - 2 lancets with damaged housing no defects were observed with the retention samples from lots c4m61k2 and c4p61m4.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 damaged, foreign matter, improper assembly, and molding defects.The indicated failure mode was attributed to the supplier.The supplier has initiated further root cause investigation relating to the issues of damaged, foreign matter, improper assembly, and molding defects 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18387021
• Report Number: 2243072-2023-02235
• Device Sequence Number: 11464213
• Product Code: FMK
• UDI-Device Identifier: 50382903665933
• UDI-Public: (01)50382903665933
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2024

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: 366593
• Device Lot Number: UNKNOWN
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 12/28/2023; 02/16/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/25/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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