MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Method: visual inspection is based off the retention samples; no testing methods performed is based off the sample.Results: no failure detected is based off the retention sample; no results available snice no evaluation performed is based off no sample.The actual device has not been returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, since sample evaluation and the retention samples of the involved lot numbers.Field sample was received and evaluated for deltoid needle detached from safety needle assembly.Field sample consisted of one risperdal consta vial.The vial contains some remnants of dry reconstituted microspheres.Attached to the vial is west medimop adapter, attached to a diluent syringe.The diluent syringe was empty with the plunger almost fully depressed.Neither a deltoid nor a safety needle was returned.Field sample is inconclusive with respect to the reported complaint of deltoid needle detached.The complaint cannot be confirm or denied.Based from the result of our investigation, the cause of the complaint could not be identified.Visual inspection revealed no defects.Retention samples were evaluated for resistance to breakage test and cannula stiffness test and all samples were compliant per iso 9626.A review of the lot history files was conducted with no findings.Prior to shipment, qc conducts outgoing visual and dimensional test and all samples for the complaint lot passed.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.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 when attempting to administer the product the needle was broken.The patient started a risperdal consta.The physician reconstituted the medication, when attempting to administer the product the needle was broken; this complaint resulted in a missed dose for the patient.It was reported that the patient was fine and received the dose the following day.Additional information received on 5/10/2018: it was reported that the needle broke as the doctor was preparing the injection.It was reported that it was the deltoid needle that was broke.

• 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, laguna ; RP
• MDR Report Key: 7591663
• Report Number: 3003902955-2018-00028
• Device Sequence Number: 217679
• Product Code: FMI
• UDI-Device Identifier: 34806017509577
• UDI-Public: 34806017509577
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 06/12/2018

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3+2125
• Device Lot Number: 170412D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/12/2018
• 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: RISPERDAL CONSTA DRUG KIT, SG3+2125; RISPERDAL CONSTA DRUG SUSPENSION; SG3+2051 FOR DELTOID/GLUTEAL INJECTION OF