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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: requested but unknown.Device was not implanted.The actual device has not been returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, and the retention samples of the involved product code/lot number combination.Visual inspection revealed no defects.Retention samples were evaluated for adhesive hold 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, functional and sensory inspections and all samples for the complaint lot passed.The investigation results verified that the retention sample was the normal product.Without the return of the actual device the exact cause cannot be definitely determined.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 while administering vivitrol using the 2-inch needle, the needle popped, and broke off.The nurse reported that as she was injecting the medication while the needle popped, broke off and the medication was still in the syringe or some of it was after it exploded as the nurse was pushing it in.The needle popped off the syringe so the nurse attached the needle to the syringe and the top part to the needle was still on but the needle broke off.The needle broke off inside the patient, but the nurse was able to the pull it out.The nurse confirmed she followed instructions for preparing vivitrol per the prescribing information and the vivitrol kit was taken out of the refrigerator to allow it to reach room temperature prior to preparing it for administration.The medication could not be administered as medication spilled onto patient and floor therefore the patient did not receive the dose of medication.

• 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: 7396511
• Report Number: 3003902955-2018-00010
• Device Sequence Number: 19140893
• Product Code: FMI
• UDI-Device Identifier: 34806017507771
• UDI-Public: 34806017507771
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3+2051
• Device Lot Number: 170529C
• 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: 03/14/2018
• Initial Report FDA Received Date: 04/04/2018
• 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: ALKERMES DRUG SUSPENSION KIT