MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® QUIKHEEL¿ LANCET; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	368101
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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® quikheel¿ lancet that the lancet is defective.Patient had to be re-stuck multiple times.No impact reported.
Event or Problem Description
It was reported that while using the bd microtainer® quikheel¿ lancet that the lancet is defective.Patient had to be re-stuck multiple times.No impact reported.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: d9: device available for eval: yes.D9: returned to manufacturer on: 02-may-2024.H6: investigation summary: bd received 45 samples for investigation.The samples were evaluated by visual examination and functional testing and the indicated failure mode for retraction failure with the incident lot was not observed.However, two lancets were observed to have partially depressed triggers (pre-activation) and with the blade exposed from the lancet.When fully activated these lancets still retracted the blade.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and functional testing and the issue of retraction failure was not observed.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 could not be confirmed for the failure mode retraction failure; however, this complaint has been confirmed for the failure mode pre-activation.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.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MICROTAINER® QUIKHEEL¿ LANCET
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19277507
• Report Number: 2618282-2024-00036
• Device Sequence Number: 7669054
• Product Code: FMK
• UDI-Device Identifier: 30382903681014
• UDI-Public: (01)30382903681014
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/13/2024

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: Health Professional
• Device Catalogue Number: 368101
• Device Lot Number: 3199118
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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