MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Establishments address - unknown.Occupation - qa compliance specialist.Based from the results of our investigation the root cause of the complaint could not be identified.Actual sample was not returned for evaluation hence we could not provide the detailed information of its actual condition.Retention samples were confirmed free from defects that will affect activation of safety sheath.Related functional testing such as sheath activation and deactivation were all passed.In addition, simulation of safety sheath manual activation was successfully done and no difficulty or irregularity on activation was encountered.We have series of visual in-process inspection to detect abnormality on the sheath that may lead to problem during sheath activation.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 problem.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Prior shipment, qc conducts outgoing visual, sensory, and functional inspection to assure lots are in good quality.All samples passed.We have proper instruction for usage of sg3 syringe with safety needle that is addressed in the ifu as provided in the leaflet in which warnings, cautions and precautions are indicated.(b)(4).
Event or Problem Description
The user facility reported that the male nurse that the protection mechanism of the cannula was used after the injection was administered but did not appear to have locked.Syringe is not available.Administration was prior to expiry date.The patient was not harmed.Additional information was received on 29july2020: the protection mechanism of the cannula did not appear to have locked.

• Brand Name: TERUMO SURGUARD3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• MDR Report Key: 10385699
• Report Number: 3003902955-2020-00028
• Device Sequence Number: 16610701
• Product Code: MEG
• UDI-Device Identifier: 34806017509287
• UDI-Public: 34806017509287
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3+03L2138
• Device Lot Number: 170516A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1