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 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 provide detailed information of its actual condition.Verification of retention samples showed no similar defect or other defects visually that might lead to the complaint and 3pcs retention samples passed functional test through cannula stiffness test and resistance to breakage test.Simulation of retention sample through normal aspiration also showed no encountered tilting/bending of cannula that could lead to broken cannula.Our needles are compliant to iso 9626 for stiffness and resistance to breakage.Verification of lot history file revealed no nonconformity encountered during production of the lot and passed series of inspections for visual, dimensional and functional test.(b)(4).
Event or Problem Description
The user facility reported that the issue occurred during a procedure when the physician was using the needle attached to a 30cc syringe and that they heard a crack and the needle broke off.Additional information was received 12august2019: it was reported that they heard a crack and the needle broke with it remaining in the anticoagulant bottle.Additional information was received 20august2019: the needle did not break inside the patient.The customer was drawing acda from a vial and the needle broke off and remained in the vial.

• 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: 8959957
• Report Number: 3003902955-2019-00035
• Device Sequence Number: 14125207
• Product Code: FMI
• UDI-Device Identifier: 34806017508082
• UDI-Public: 34806017508082
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3-1838
• Device Lot Number: 171102D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1