MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: qa specialist.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Lot history files of the complaint lot were checked and no related nonconformity or irregularity was noted that may lead to failure in safety sheath activation.Similarly, retention samples were visually in good condition and passed the sheath activation and deactivation functional test.We have series of visual in-process inspection to check the molding condition of the components critical to the safety activation of the product.This is routinely checked to assure that no defects will be encountered that will lead to problem in activation.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 to shipment, qc conducts an outgoing visual inspection to also check the condition of our finished products wherein all samples passed.Proper instruction for usage of the sg2 safety needle device activation including warnings to avoid needle sticks is fully addressed in the instructions for use (ifu) printed on the leaflet terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo ((b)(6)) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that after the injection, the safety needle could not be completely closed and covered.Causing a needle stick to the nurse.Additional information was received on 23april2021: the nurse was stuck by the needle.Her injury was recovered.She had a blood test and the results showed no infection.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.Based on our investigation, the root cause of the complaint is not related to our product or process.The received 2 pieces actual sample showed one sample was already activated while the safety sheath of another sample (sample 1) was not yet activated and cannula bending was also observed.The sample was then subjected to simulation through manual sheath activation.The simulation showed that although the needle was bent, the safety sheath was still successfully activated - an audible click was heard and the needle was fully engaged under the lock (sheath tooth).Similarly, retention samples were visually in good condition and passed the sheath activation and deactivation functional test.Also, the retention samples subjected to simulation showed no irregularity during manual sheath activation.We have series of visual in-process inspections to check the molding condition of the components critical to the activation of the product.Lot history files of the complaint lot were checked and no related nonconformity or irregularity was noted.Moreover, instructions for use addressed the proper device activation of the sg2 safety needle including having an audible click that will indicate successful activation and visual confirmation that the needle is fully engaged under the lock to avoid needle sticks.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

• Brand Name: TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• MDR Report Key: 11825640
• Report Number: 3003902955-2021-00011
• Device Sequence Number: 1085422
• Product Code: MEG
• UDI-Device Identifier: 34806017507122
• UDI-Public: 34806017507122
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: SG2+2525
• Device Lot Number: 191125B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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: FIRMAGON 80 MG POWDER.; SOLVENT FOR SOLUTION FOR INJECTION.; SYRINGE, DRUG VIAL, RUBBER STOPPER OF VIAL.