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	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved needle was broken using risperdal consta.The product was not administered to the patient and the patient's health was not harm.The event occurred pre-treatment.The final patient impact was not harmed.The patient was not injured during the event and medical/surgical intervention was not needed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age or date of birth: requested, not provided.A3a: sex: requested, not provided.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.E1: phone number: requested, unknown.E3: occupation: combo analyst iii, product quality vigilance.The actual device was not available for evaluation therefore; the details of the actual condition of the sample in unable to be determined.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.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.Prior to the supply of cannula (raw material) to the needle assembly process, qc conducts incoming inspection which includes dimensional inspection and verification of certificate of analysis according to material specification.A total of ten (10) 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.Retention 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 40x 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 and the retention samples met the required specifications.Our cannula is supplied with raw material that complies with iso 9626, particularly on stiffness and breakage.The retention samples were confirmed visually in good condition.Simulations were conducted on the samples wherein the needle did not break even after 40x bending which indicates that our needles have high resistance to breakage.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, binan ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 18911506
• Report Number: 3003902955-2024-00015
• Device Sequence Number: 6769186
• Product Code: FMI
• UDI-Device Identifier: 34806017507771
• UDI-Public: 34806017507771
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SG3+2051
• Device Lot Number: 221216C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2022
• 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: RISPERDAL CONSTA
• Patient Sex: Unknown