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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: quality engineer.The actual sample was not available for our evaluation.The root cause of the complaint could not be identified to be related to our production or process.The retention samples were confirmed visually in good condition.Simulation were conducted on the retention samples wherein the needle did not break even after 40x bending which indicates that our needles have high resistance to breakage.We have received three complaints covering fy20 to fy22 (july 4, 2022), related to this issue where the cause was not identified related to our product and production process.Our cannula is supplied raw material that complies with iso 9626, particularly on stiffness and breakage.Moreover, cannula incoming inspection includes dimensional inspection and verification of certificate of analysis according to material specification.We have an online and in-process visual inspection to check bent or damage to the cannula that might lead to the complaint.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Before shipment, qc conducts outgoing inspection that includes visual checking such as bent or damage on the cannula.All samples passed.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that a risperdal consta 50mg needle broke when administered.There was no patient injury or was medical or surgical intervention required.

• Brand Name: TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; biñan, phl ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna, ; RP
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15091072
• Report Number: 3003902955-2022-00022
• Device Sequence Number: 5160705
• Product Code: FMI
• UDI-Device Identifier: 34806017509577
• UDI-Public: 34806017509577
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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
• Device Expiration Date: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: SG3+2125
• Device Lot Number: 211015C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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