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

Model Number	366593
Medical Device Problem Codes	Crack (1135); Solder Joint Fracture (2324); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is mfg oem 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 b3.The date received by manufacturer has been used for this field.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 the bd microtainer® contact-activated lancet that there was foreign mater on the device needle, blade molding defect.The following information was provided by the initial reporter: he customer returned complaint products, reporting about scratched/dirty/cracked products and burrs.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 6 shelf packs of samples for investigation.The samples were evaluated by visual examination and the indicated failure modes for foreign matter, cracked shield, and shield molding defect with the incident lot were observed.Additionally, retention samples from bd inventory were evaluated by visual examination and upon completion the indicated failure mode for cracked shield was observed in 1 lancet.No molding defects or foreign matter were found in the retention samples.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 foreign matter, cracked shield, and shield molding defect.Bd has initiated further root cause investigation relating to the issues of foreign matter, cracked shield, and shield molding defect through corrective and preventive actions.The following fields were updated due to additional information: d9: device available for evaluation:  yes d9: returned to manufacturer on: 2023-06-15 see h.10.
Event or Problem Description
It was reported that while using the bd microtainer® contact-activated lancet that there was foreign mater on the device needle, blade molding defect.The following information was provided by the initial reporter: he customer returned complaint products, reporting about scratched/dirty/cracked products and burrs.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17240956
• Report Number: 2243072-2023-01166
• Device Sequence Number: 6698237
• Product Code: FMK
• UDI-Device Identifier: 50382903665933
• UDI-Public: 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
• Report Date (Section B): 07/19/2023

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 Model Number: 366593
• Device Catalogue Number: 366593
• Device Lot Number: C4F19E7
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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