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

Model Number	366594
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: 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 when using the bd microtainer® contact-activated lancet the lancet breaks off and there is a retraction issue.The following information was provided by the initial reporter.The customer stated: "lancet left the metal lancet within their finger after use." there was no further report of injury or required medical inventions provided.
Additional Manufacturer Narrative
H6: investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure modes with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to did not retract/metal left in finger 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 modes.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet the lancet breaks off and there is a retraction issue.The following information was provided by the initial reporter.The customer stated: "lancet left the metal lancet within their finger after use." there was no further report of injury or required medical inventions provided.
Additional Manufacturer Narrative
Imdrf annex a code changed from a1503 to a0401.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet the lancet breaks off and there is a retraction issue.The following information was provided by the initial reporter.The customer stated: "lancet left the metal lancet within their finger after use." there was no further report of injury or required medical inventions provided.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16010026
• Report Number: 2243072-2022-02184
• Device Sequence Number: 5784030
• Product Code: FMK
• UDI-Device Identifier: 50382903665940
• UDI-Public: 50382903665940
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2023

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: 366594
• Device Catalogue Number: 366594
• Device Lot Number: C3K11C4
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 12/23/2022
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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