MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD HENRY SCHEIN; SYRINGE NEEDLE

Model Number	18G*1
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Voluntary report #'s mw5172340 and mw5172341 were sent to henry schein.Per both reports stated by the 25-year-old female patient: "i went to do my hormone injection tonight and noticed metal shards in two different needles from the same lot.I noticed the first before pushing the air into the vial.I took it out, took a picture of the wrapper, and disposed it in my sharps box.I checked the vial for anything floating and then opened a new needle and attached it to the syringe.I drew up the air, injected it slowly into the vial to watch for anything coming out of the needle and saw a small shard of metal come out of the needle.I sucked it into the syringe and took pictures of the shard in syringe before disposing the needle and syringe in my sharps box.This happened two weeks ago, and my pharmacist and physician had me dispose of the vial and purchase a new one.I will notify them in the morning.The needles were: henry schein hypodermic needle ref (b)(4) size 18gx1" lot 20240728 2029-07-27."item # 9004469.Reference voluntary report #'s mw5172340 and mw5172341.
Additional Manufacturer Narrative
Upon receipt of the customer complaint, kdl performed investigations including retained sample test and process review.

• Brand Name: HENRY SCHEIN
• Common Device Name: SYRINGE NEEDLE
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD; no.658, gaochao road,; jiading district,; shanghai, shanghai 20180 3; CH 201803
• Manufacturer (Section G): SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD; no.658, gaochao road,; jiading district,; shanghai, shanghai 20180 3; CH 201803
• Manufacturer Contact: wendy yao ; no.658, gaochao road,; jiading district,; shanghai, shanghai 20180-3 ; CH 201803
• MDR Report Key: 22724067
• Report Number: 3005405146-2025-00001
• Device Sequence Number: 8288381
• Product Code: FMI
• UDI-Device Identifier: 00304040002810
• UDI-Public: 00304040002810
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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 Model Number: 18G*1
• Device Catalogue Number: 900-4469
• Device Lot Number: 20240728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2024
• 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: Female