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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 visually in good condition and passed the adhesive hold test.We have adhesive hold test to check bonding strength between needle and hub during needle assembly.In addition, the epoxy condition of the needles is visually inspected.Thus, condition of product is assured prior supply to sg production.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 and the needle fell out as soon as it was opened.There was no patient impact it was pretreatment.The staff was peeling open unused product prepping for a flu vaccine.There was no procedure impact as the product was not used for the procedure.Additional information received on (b)(6) 2018: it was reported that the needle (steel from needle hub) fell out as soon as it was opened.
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 defect was found that may result in detached cannula.Both retention samples and received unused same lot samples were visually in good condition and passed the adhesive hold test.

• 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: 8189012
• Report Number: 3003902955-2018-00052
• Device Sequence Number: 11238047
• 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