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

Catalog Number	366594
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The manufacturing location for this product is 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.
Event or Problem Description
It was reported that after patient's finger was punctured with the bd microtainer® contact-activated lancet, a small piece of metal broke off into patient's finger.Patient complained of pain at the site of the puncture after the fingerstick.Patient subsequently had an x-ray which revealed there was a piece of metal in her finger.Patient then had a surgical procedure to have piece of metal removed and was treated with antibiotics.Verbatim: "customer reporting that a small piece of metal broke off into the patients finger after the finger was punctured with the lancet.The patient complained of pain after the fingerstick at the site of the puncture.Patient subsequently had an x-ray which revealed there was a piece of metal in her finger.She then had surgery to have the piece of metal removed and was treated with antibiotics.".
Additional Manufacturer Narrative
Type of reportable events: serious injury.
Event or Problem Description
It was reported that after patient's finger was punctured with the bd microtainer® contact-activated lancet, a small piece of metal broke off into patient's finger.Patient complained of pain at the site of the puncture after the fingerstick.Patient subsequently had an x-ray which revealed there was a piece of metal in her finger.Patient then had a surgical procedure to have piece of metal removed and was treated with antibiotics.Verbatim: "customer reporting that a small piece of metal broke off into the patients finger after the finger was punctured with the lancet.The patient complained of pain after the fingerstick at the site of the puncture.Patient subsequently had an x-ray which revealed there was a piece of metal in her finger.She then had surgery to have the piece of metal removed and was treated with antibiotics".
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: 12/08/2023.H.6 investigation summary material #: 366594.Lot/batch #: c7e29m4.Bd received 14 samples for investigation.The samples were evaluated by visual examination, each disassembled and observed under 10x magnification, and the indicated failure mode for blade broke off with the incident lot was not observed.All 14 lancet blades were observed without any defects.Additionally, retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to blade broke off as all samples met specifications.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 is unable to be confirmed for the indicated failure mode blade broke off.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.
Event or Problem Description
It was reported that after patient's finger was punctured with the bd microtainer® contact-activated lancet, a small piece of metal broke off into patient's finger.Patient complained of pain at the site of the puncture after the fingerstick.Patient subsequently had an x-ray which revealed there was a piece of metal in her finger.Patient then had a surgical procedure to have piece of metal removed and was treated with antibiotics.Verbatim: "customer reporting that a small piece of metal broke off into the patients finger after the finger was punctured with the lancet.The patient complained of pain after the fingerstick at the site of the puncture.Patient subsequently had an x-ray which revealed there was a piece of metal in her finger.She then had surgery to have the piece of metal removed and was treated with antibiotics.".

• 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: 18241796
• Report Number: 2243072-2023-02122
• Device Sequence Number: 7059566
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: (01)50382903665940
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2023

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: C7E29M4
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 12/27/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/06/2023; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown