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

Catalog Number	366594
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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." oem manufacturer: 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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet a customer got her finger stuck while picking up the trash.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that she stuck her finger with a discarded blue and white bd contact activated lancet while picking up trash.Was it a clean needle or a used needle: dirty discarded needle.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet a customer got her finger stuck while picking up the trash.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that she stuck her finger with a discarded blue and white bd contact activated lancet while picking up trash.Was it a clean needle or a used needle: dirty discarded needle.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: b1.Corrected to adverse event as no product problem was alleged.B2.Event attributed to: removed 'required intervention' as no intervention was alleged.B2.Other details: corrected from 'na' to 'needle stick injury'.

• 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: 18216876
• Report Number: 2243072-2023-02098
• Device Sequence Number: 20486507
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: (01)50382903665940
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 366594
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown