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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A3b: gender: n/a a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted.The actual sampled was discarded; therefore, the actual condition of the sample was unable to be determined.Retention samples were visually inspected and confirmed free from any tilted cannula, bent cannula, or damage to cannula that might lead to the complaint.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.The supplied cannula raw material is tpc inspected wherein the overall visual condition of the cannula has been checked.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.The retention samples were subjected to simulation testing.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.Results, the needle did not break even after 40 times bending.The root cause of the complaint could be a user error, the user tried to deactivate the safety needle which caused the needle to snap in half.The user did not follow the mckesson sg3 safety needle device cautions, by forcing the needle out of the safety sheath.Mckesson sg3 safety needle device usage cautions are fully addressed in the leaflet; do not attempt to deactivate the safety device by forcing the needle out of the safety sheath.Our cannula is supplied with raw material that complies with iso 9626, particularly 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.We advise you to follow the instructions for use (ifu) indicated in the leaflet for the proper usage of mckesson sg3 safety needles in which warnings, cautions, and precautions are also included.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.
Event or Problem Description
The patient (user) reported that the involved needle broke, and the medication is expired.It was reported that the perseris medication was mixed and sat out too long.Therefore, it was discarded to prevent the risk of giving expired medication.The user also explained that the needle also snapped, and there was no way to put it back on the medication.The user stated the perseris 90 mg was shipped to on 19 mar 2024, and the perseris 90 mg was mixed on 03 apr 2024 and placed back in the refrigerator.The user did not have storage information and discarded the medication on the evening of 03 apr 2024.The user confirmed that the safety cap was on the needle, however when she attempted to remove it, is when the needle itself snapped in half.

• 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: 19266207
• Report Number: 3003902955-2024-00026
• Device Sequence Number: 7383988
• Product Code: FMI
• UDI-Device Identifier: 34806017510702
• UDI-Public: 34806017510702
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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
• Device Lot Number: 221022C
• 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: 04/08/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2022
• 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 90 MG
• Patient Age: 20 YR
• Patient Sex: Female