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

Catalog Number	366594
Medical Device Problem Codes	Break (1069); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this mdr, bd corporate headquarters in (b)(4) has been listed as high tech labs is an oem manufacturing site.Initial reporter phone: (b)(6).Medical device lot#: batch a7j99s2 does not exist for material 366594.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet, the device experienced the lancet breaking off.This event occurred once.There is no mention of medical intervention or removal type of the needle.The following information was provided by the initial reporter.The customer stated: we¿ve had a customer raise an issue where the tip of a lance has broken off in a patient¿s hand.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet, the device experienced the lancet breaking off.This event occurred once.There is no mention of medical intervention or removal type of the needle.The following information was provided by the initial reporter.The customer stated: we¿ve had a customer raise an issue where the tip of a lance has broken off in a patient¿s hand.
Additional Manufacturer Narrative
Imdrf annex a code changed from a150303 to a0401.
Additional Manufacturer Narrative
Investigation summary: material#: 366594, lot/batch#: a7j99s2.Bd had not received samples or photos for investigation.Therefore, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to broken during use 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.Bd was not able to identify a root cause for the indicated failure mode.Bd manufactures several million safety lancets each and every day with the most comprehensive quality assurance procedures to meet the highest standards.We would like to stress that our product meets all applicable standards.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.
Event or Problem Description
It was reported when using the bd microtainer® contact-activated lancet, the device experienced the lancet breaking off.This event occurred once.There is no mention of medical intervention or removal type of the needle.The following information was provided by the initial reporter.The customer stated: we've had a customer raise an issue where the tip of a lance has broken off in a patient¿s hand.

• 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: 15642138
• Report Number: 2243072-2022-01803
• Device Sequence Number: 17562171
• Product Code: FMK
• UDI-Device Identifier: 00382903665945
• UDI-Public: 00382903665945
• 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): 07/15/2024

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: 366594
• Device Lot Number: SEE H.10.
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 01/18/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 01/13/2023; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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