MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved injection needle broke.The pharmacy delivered a new box.The pharmacy threw away the defective product.The event occurred pre-treatment.There was no patient involvement.Before injection the needle was found broke, and the treatment was stopped.
Additional Manufacturer Narrative
Expiration date: 31-jul-2026 (date was filled in however is showing up blank in the print view of the medwatch).Operator of device: unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation: unknown.The actual sample was not available for evaluation.The root cause of the complaint could not be identified to be related to our product or production process.The retention samples were confirmed visually in good condition.Simulation were conducted on the samples wherein the needle did not break even after 40x bending which indicates that our needles have high resistance to breakage.Our cannula is supplied raw material that complies with iso 9626, particularly on stiffness and breakage.We have received nine (9) complaints covering fy20 to fy22 (august 16, 2022), related to this issue where the cause was not identified related to our product and production process.We have an online and in-process visual inspection to check bent or damage to the cannula that might lead to the complaint.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Before shipment, qc conducts outgoing inspection that includes visual checking such as bent or damage on the cannula.All samples passed.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo corporation (manufacturer) registration no.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to add section h6: in investigation conclusion.

• Brand Name: TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; biñan, phl ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna, ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15333349
• Report Number: 3003902955-2022-00033
• Device Sequence Number: 6487023
• Product Code: MEG
• UDI-Device Identifier: 34806017507122
• UDI-Public: 34806017507122
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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
• Device Model Number: N/A
• Device Catalogue Number: SG2+2525
• Device Lot Number: 210824B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown