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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved needle was used to drain an abscess.When the provider was finished, she was unable to get the safety device to click in place over the needle.When she proceeded to put the needle in the sharp's container, she incurred a needle stick in her finger.Other needles out of the same box and engaged the safety device.
Additional Manufacturer Narrative
B3: date of event: requested, unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: quality manager.We were unable to determine the details of the actual condition of the sample as it was not available for evaluation.Retention samples were visually inspected and confirmed free from defects that will affect activation of the safety sheath such as missing tooth, tooth flash, short shot, flash on the sheath, over or under insertion collar to the hub, sheath-collar fitting, tilted cannula, and damaged parts.The samples were further evaluated for sheath activation and deactivation functional test wherein all samples passed.A total of twenty-two (22) complaints were received from the previous two fiscal years to the present for the same issue where most of the problems are related to usage particularly due to improper activation of the device (not activating with a one-handed technique using the three methods: finger, thumb, and hard surface).Based on the investigation of individual complaints there was no attributable cause noted related to our product and production process.The retention samples were subjected to simulation.The safety needle was securely tightened to the syringe with a clockwise twisting motion until resistance was felt.The safety sheath was activated with a one-handed technique using the three methods: finger, thumb, and hard surface.An audible click was heard indicating successful safety activation.The cannula is fully engaged under the lock (sheath tooth).No irregularity was encountered during and after sheath activation.The root cause of the complaint could not be identified to be related to our product or production process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot.Series of visual in-process inspections to detect an abnormality on the sheath that may lead to a problem during sheath activation.The molding condition of the components critical to the safety activation of the product is routinely checked to assure that no defects will be encountered that will lead to sheath activation problems and needle sticks.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.We advise to follow the instructions for use (ifu) indicated in the leaflet for the proper usage of sg3 safety needle in which warnings to prevent needle stick, 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.

• 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: 18422891
• Report Number: 3003902955-2023-00070
• Device Sequence Number: 18104644
• Product Code: FMI
• UDI-Device Identifier: 34806017508075
• UDI-Public: 34806017508075
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2023

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: SG3-1825
• Device Lot Number: 220312C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2022
• 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: Female