MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER QUIKHEEL PREEMIE LANCET; SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE

Catalog Number	368100
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use of the bd microtainer quikheel preemie lancet, there was foreign matter observed on one of the lancet packages.There were no health impact or consequences reported.
Additional Manufacturer Narrative
E.1: initial reporter phone #: (b)(6).Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for foreign matter was observed.Additionally, 40 retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter 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 has been confirmed for the indicated failure mode foreign matter.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 PREEMIE LANCET
• Common Device Name: SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20323562
• Report Number: 2618282-2024-00137
• Device Sequence Number: 15455166
• Product Code: FMK
• UDI-Device Identifier: 30382903681007
• UDI-Public: (01)30382903681007(11)230623(17)280430(10)3139316
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/31/2024

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: 368100
• Device Lot Number: 3139316
• 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: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• 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