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	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a 2-year-old male cat was sedated using the involved terumo surguard 3, 25 gauge, 5/8 "length.The cat received an intramuscular injection for sedation before the start of a surgical procedure.The injection was given in the right hindleg.Upon removal of the needle, it was noted that the entire needle was left in the muscle and the needle broke at the hub.The cat was referred to a large specialty hospital and the needle was removed using fluoroscopy.The cat survived the procedure and is doing well.Surgical removal of the needle from the right hindleg using fluoroscopy.Patient injury and/or medical or surgical intervention required.Patient condition is stable.The event occurred intra-operative.
Additional Manufacturer Narrative
A1: patient identifier: orange, nuetered, male domestic short hair feline.A4: weight: 5.36 lbs.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: senior medical veterinary officer.The actual device is not available for return, therefore the details of the actual condition of the sample as was unable to be determined.Retention samples were visually inspected and confirmed free from any tilted cannula, bent cannula, or damage on cannula that might lead to the complaint.Retention samples were subjected to simulation.The syringe with 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 40 times.A total of six (6)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 root cause of the complaint could not be identified to be related to our production 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.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

• 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: 17981367
• Report Number: 3003902955-2023-00056
• Device Sequence Number: 19446437
• Product Code: FMI
• UDI-Device Identifier: 34806017508198
• UDI-Public: 34806017508198
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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: SG3-2516
• Device Lot Number: 220813D
• 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: 09/21/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2022
• 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 Age: 2 YR
• Patient Sex: Male
• Patient Weight: 2 KG