MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that following administration of sublocade 300mg the patient developed a skin infection.The device problem occurred after the use.The incident has not led to a serious deterioration in the state of health to the patient.The event was not caused by user error.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual sample was not available for our evaluation hence we could not determine the details of its actual condition.Visual inspection of the retention samples confirmed that they were free of burr/bent, damaged needle tip, foreign material, scratch, bent cannula, or any other contributing defects that would lead to the complaint.A corrective action is not necessary for this complaint.We received four (4) complaints related to this issue from fy20 to fy22 (april 3, 2023) where the cause was not identified as being related to our product or production process.The root cause of the complaint could not be linked to our product or manufacturing process.Our needles are non-toxic, pyrogen-free, and do not contain any toxins or harmful substances that are poisonous and may cause fever when injected into the bloodstream.Every lot is tested for the presence of bacterial endotoxin to ensure that our products are safe to use and will not harm the patient.We also have monthly physicochemical tests to check for metal and alkaline traces.All finished products are sterilized using the electron beam sterilization process, and qc performs outgoing visual and sensory inspections to ensure that the products are in good condition before shipment.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

• Brand Name: TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16767919
• Report Number: 3003902955-2023-00014
• Device Sequence Number: 3252352
• Product Code: FMI
• UDI-Device Identifier: 34806017510719
• UDI-Public: 34806017510719
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/19/2023

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3+1916
• Device Lot Number: 180115C
• 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: 03/23/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SUBLOCADE 300 MG
• Patient Sex: Unknown