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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: quality record coordinator.The actual condition of the sample could not be determined as the actual sample was not available.Retention samples were visually inspected and confirmed free from any tilted cannula, bent cannula, or damage to the cannula that might lead to the complaint.Device history records and process checks confirm no nonconformity reports related to human error were issued during lot production.A total of fourteen (14) 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 underwent a simulation test: the syringe with safety needle was punctured into the rubber cork.This was followed by a manual cannula bending test, where the needle was bent at a 45° angle from left to right forty times.Outcome: the needle remained intact, showing no breakage after repeated bending.The root cause of the complaint could not be identified to be related to our product or manufacturing process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot.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.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.
Event or Problem Description
The user facility reported that the involved needle detached during the injection process.The event occurred intra-operative.The patient was not injured during the event and medical/surgical intervention was not needed.

• 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: 19480755
• Report Number: 3003902955-2024-00032
• Device Sequence Number: 7905350
• Product Code: FMI
• UDI-Device Identifier: 34806017510719
• UDI-Public: 34806017510719
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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
• Device Model Number: N/A
• Device Catalogue Number: SG3+1916
• Device Lot Number: 220810C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2022
• 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
• Patient Sex: Unknown