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

Model Number N/A

Device Problem Break (1069)

Patient Problems Needle Stick/Puncture (2462); Insufficient Information (4580)

Event Date 12/28/2023

Event Type  malfunction  

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.D4: product code: potential codes: 1) sg3+2051, 2) sg3+2051, 3) sg3+2125, & 4) sg3+2125.D4: lot #: potential no's.: 1) 221008c, 2) 221220c, 3) 221013c, & 4) 221115c.D4: expiration date: potential dates: 1) 30 sep 2027, 2) 30 nov 2027, 3) 30 sep 2027 & 4) 31 oct 2027.D4: udi: potential udi's: 1&2) (b)(4), 3&4) (b)(4).D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: requested, unknown.E3: occupation: requested, unknown.H4: device manufacture date: potential dates: 1) 08 oct 2022, 2) 20 dec 2022, 3) 13 oct 2022 & 4) 15 nov 2022.The actual sample was discarded and not available for evaluation therefore the details of the actual condition of the sample in unable to be determined.The 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 the sheath activation and deactivation functional test wherein all samples passed.A total of twenty-eight (28) 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 or manufacturing process.The retention samples were subjected to simulation as per ifu.The safety needles were 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 three methods: finger, thumb, and hard surface.An audible click was heard indicating successful safety activation.Results: the cannula is fully engaged under the lock (sheath tooth).No irregularity or bending of the cannula was encountered during and after sheath activation.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.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 ensure 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 you to follow the instructions for use (ifu) indicated in the leaflet for the proper usage of sg3 safety needles in which warnings to prevent needle stick, cautions, and precautions are also included.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved needle stuck a nurse on her finger when she attempted to engage the safety on the needle after administering an injection to a patient.The white stopper at the end of the syringe broke off and stuck her in the finger.The full dose was administered to the patient.The patient did not suffer any harm from this problem.The sample has already been discarded and is not available for return.

• Brand Name: SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Type of Device: 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: 18910078
• MDR Text Key: 337746609
• Report Number: 3003902955-2024-00007
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RISPERDAL CONSTA INJECTION KIT 50.00 MG