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 Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - not provided.Age & date of birth - not provided.Patient sex - not provided.Weight - not provided.Ethnicity - not provided.Race - not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Reporter occupation: health professional - clinical value analysis specialist.Based on our initial investigation, the root cause of the problem could not be identified yet.The sample for return is not yet received as of this time hence we could not provide detailed information of its actual condition.Evaluation will be conducted once the sample is received.Retention samples were visually confirmed free from defects that will affect activation of safety sheath and passed the evaluation for sheath activation and deactivation functional test.Also, no irregularity was encountered during the simulation of manual sheath activation.The safety sheath is fully engaged and the cannula is securely locked on the sheath tooth.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior shipment, qc conducts outgoing visual, sensory, and functional inspections to assure lots are of good quality.This complaint is still an ongoing investigation.Therefore, a final answer card will be provided once the investigation was completed.No corrective action is taken as of this time.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo ((b)(4)) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported the needle did not recap completely (stiff), the patient was stuck in the left index finger.The needle is part of the abilify maintena 400 mg kit.Additional information was received on 15april2021: the needle stick injury was to healthcare worker on completion of administration of the med.Healthcare worker had minimal blood loss.The condition of the patient was not disclosed.The complete dose was provided.Healthcare worker was followed up by (b)(6) for testing after needle stick injury.Results unknown.The needle pertains to the cap, the safety sheath.It is unknown what method of activation was used.
Additional Manufacturer Narrative
Based on the result of the investigation, the root cause of the complaint could not be identified.The actual sample was not returned for investigation instead unused other lot sample (191209d) was received.The received other lot sample and retention lot samples were visually in good condition.No related defects were noted that may cause problems in safety sheath activation.The retention samples passed the evaluation for sheath activation and deactivation functional test.Both the received other lot sample and retention samples were subjected to manual sheath activation wherein no problem was encountered on both simulations and an audible click was heard indicating successful safety activation.The safety sheath is fully engaged and the cannula is securely locked on the sheath tooth.We have series of visual in-process inspections to detect an abnormality on the sheath and collar.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.Components are checked for any presence of defects such as tooth flash, missing tooth, damaged collar ear, and over or under insertion of the collar to the hub.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.

• 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
• MDR Report Key: 11770280
• Report Number: 3003902955-2021-00013
• Device Sequence Number: 11536064
• Product Code: FMI
• UDI-Device Identifier: 34806017509669
• UDI-Public: 34806017509669
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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 Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SG3+2238
• Device Lot Number: 180911D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABILIFY MAINTENA 400 MG