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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a patient admitted that the needle broke while in the process of preparation as it was not broken when the box was opened.Another 12-gauge needle was planned to be used.The health care provider (hcp) is aware that of self-administering the medication.The event occurred intra-operative.
Additional Manufacturer Narrative
The actual sample was not available for evaluation; therefore, the details of its actual condition could not be determined.Since the lot number is unknown, an evaluation was not performed.A total of thirteen (13) complaints were received from the previous two fiscal years to the present for the same issue where the cause was not identified related to our product and production process.Representative samples were subjected to simulation.The syringe with the safety needle was punctured into the rubber cork.A manual cannula bending test was conducted wherein the needle was bent 45° from left to right forty (40) times.Result, the needle did not break even after forty (40) times of bending.The root cause of the complaint could not be identified to be related to our production or manufacturing process.Our cannula is supplied with raw material that conforms to iso 9626, specifically on stiffness and breakage.We have a series of inspections from the needle assembly process to the outgoing process that check the conditions of the safety needles.Only lots that passed the inspection are allowed to be shipped.Terumo medical products (tmp) (importer) registration no.2243441 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, binan ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 19188811
• Report Number: 3003902955-2024-00024
• Device Sequence Number: 15571786
• Product Code: FMI
• UDI-Device Identifier: 34806017510702
• UDI-Public: 34806017510702
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: SG3+1816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PERSERIS INJECTION UNSPECIFIED
• Patient Sex: Unknown