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

Catalog Number	366592
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
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 (b)(4), 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.D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.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 prior to using a bd microtainer® contact-activated lancet, the protective cap was not attached to the lancet.No impact was reported.
Event or Problem Description
It was reported prior to using a bd microtainer® contact-activated lancet, the protective cap was not attached to the lancet.No impact was reported.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 09-sep-2024.Medical device lot #: c9f59j1.Unique identifier (udi) #: (b)(4).Medical device expiration date: 27-jul-2027.Device manufacture date: 10-oct-2022.Investigation summary: bd received 1 sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for hub molding defect with the incident lot was observed.This molding defect led to the cap being loose.Additionally, retention samples from bd inventory were evaluated by visual examination and the issue of hub molding defect or loose cap 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 hub molding defect.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 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: 20013113
• Report Number: 2243072-2024-00906
• Device Sequence Number: 7257881
• Product Code: FMK
• UDI-Device Identifier: 30382903665922
• UDI-Public: (01)30382903665922(11)221010(17)270727(10)C9F59J1
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 366592
• Device Lot Number: C9F59J1
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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