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

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned to the manufacturing facility.Based on the results of our investigation, the root cause of the complaint could not be identified.Since actual sample was not returned for evaluation, we cannot determine the details of its actual condition.Retention samples were visually inspected.The actual product sg3+2038 is the same with the indication on the blister packaging.No incorrect packing of product was noted.Our collar machine has inspection system for bevel orientation and tip inspection which can detect if the needle length was not correct based on the machine set up.Line clearance is conducted before and after production of lot at collar assembly and manual sheath assembly.Based on our record, 2038 (1 ½") and 2025 needles (1") was simultaneously run at collar machine 2 and 4 respectively.Moreover, line clearance was done accordingly based on our records.No contamination similar to complaint was encountered.We have series of visual in-process inspection to confirm the products for any defects.Prior shipment, qc outgoing inspection conducts visual inspection to check the condition of the assembled products.All samples passed.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 alkermes, inc.Received an issue report involving the terumo 1 1/2" needle being packaged incorrectly.Naltrexone sa injection from alkermes pharmaceuticals lot had 1 inch needles included in packaging labeled as 1.5 inch needles.Nurses noted and did not administer to patients.Used 1.5 inch needles available separately in the clinic.

• 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, ; RP
• MDR Report Key: 8704980
• Report Number: 3003902955-2019-00029
• Device Sequence Number: 11223781
• Product Code: FMI
• UDI-Device Identifier: 34806017508686
• UDI-Public: 34806017508686
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3+2038
• Device Lot Number: 180118C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1