MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SYRINGE WITH SAFETY NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - no patient involvement, age & date of birth - no patient involvement, sex - no patient involvement, weight - no patient involvement, ethnicity - no patient involvement, race - no patient involvement, implanted date: device was not implanted, explanted date: device was not explanted.The actual device has not been returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon evaluation of user facility information, and evaluation of retention sample.Based on the results of our investigation, the cause of the complaint could not be identified since condition of the actual sample was not confirmed.Retention samples were confirmed free from defects such as tooth flash, missing tooth, damaged collar ear, sheath collar fitting, and over or under insertion of collar to hub.Related functional testing such as sheath activation and deactivation were all passed.Molding condition of the components critical to the safety activation is checked to assure that no defects will be encountered that will lead to sheath activation problem.In addition, no difficulty was encountered during the simulation of retention samples.An audible click was heard indicating successful safety activation.The cannula is securely locked and no irregularity and bending or tilting of cannula was noted.We have in-process inspection for visual, sensory test and functional test to assure quality performance of assembled sg2 needle.Prior shipment, qc conducts outgoing inspection to assure lots are in good quality.All samples passed.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.Exemption number e2015017.
Event or Problem Description
The user facility reported that the syringe with safety needle safety mechanism is faulty.The safety mechanism did not catch.There was no patient impact.There was no procedure impact as the product was not being used for a procedure.Additional information received on (b)(6) 2018: it was reported that the device was either very difficult to engage "they had to push very hard", or became disengaged from the safety feature.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device returned date and to provide the completed investigation results.Twenty pieces of unused same lot samples were returned to the manufacturing facility for evaluation.No defects were found that may result to the complaint.Based on the results of our investigation, the cause of the complaint could not be identified.Received unused same lot samples were visually inspected and no defects were found that may result in activation failure.Moreover, samples undergone relative testing such as sheath activation and deactivation.All samples are within specification.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SYRINGE WITH SAFETY NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• MDR Report Key: 8189018
• Report Number: 3003902955-2018-00050
• Device Sequence Number: 1997553
• Product Code: MEG
• UDI-Device Identifier: 30612479179067
• UDI-Public: 30612479179067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 102-SN3C231S
• Device Lot Number: 171020A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1