MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: qa specialist.Investigation findings: 114 is based on the details of complaint; 213 is based on the retention samples.Since the sample was not returned for evaluation, we could not provide the detailed information of its actual condition.Additional information received confirmed the defect most likely happened during usage since the complaint sg2 needle should only be used for subcutaneous injection.Retention samples were subjected to simulation.Aspiration from a vial of reconstituted medicine (benzylpenicillin) was successfully conducted then syringe was connected to the sg2 needles followed by injection to dummy arm.No tilted/bent or broken cannula was encountered during simulation similar to the complaint.Our cannula as supplied raw material complies with iso 9626, particularly on stiffness and breakage.We have series of visual inspection to check the condition of the product that might lead to the complaint.Prior shipment, qc conducts outgoing inspection that includes visual checking such as bent, or damage on cannula.Lot history files showed no nonconformity encountered that will lead to the complaint (b)(4).
Event or Problem Description
The user facility reported that after the nurse reconstituted the product (he/she) then tried to administer it to the patient, the needle broke.The user tried to insert the needle into the vial is when the needle broke, and the liquid leaked out.The procedure was not successful.The patient was not able to get the dose.The needle did not break in patient's skin.There was no patient injury, medical/surgical intervention required.The patient was not harmed.

• Brand Name: TERUMO SURGUARD2 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: 10725757
• Report Number: 3003902955-2020-00035
• Device Sequence Number: 3180478
• Product Code: FMI
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: SG2+2525
• Device Lot Number: 190520B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/23/2020
• 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: FIRMAGON