MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON PREVENT ® HT SYRINGES WITH 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	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the needle broke inside the vial when the physician prepared the vaccine.Additional information received 07 apr 2022: the doctor was mixing medication "proquad" aspirating from glass vial prior to the vaccine delivery, when accessing the medication, the needle broke off and fell into the vial.They looked at the needle and did not see any bend in the needle and then disposed the needle and vaccine.They mixed a new vaccine to resolve the issue for patient injection.Patient was not impacted in any way and is stable/healthy.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter health professional: manager - department of pediatrics.The root cause of the complaint could not be identified to be related to our production or process.The actual sample was not available for evaluation.The retention samples were confirmed visually in good condition.Simulation were conducted on the samples wherein 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.Moreover, cannula incoming inspection includes dimensional inspection and verification of certificate of analysis according to material specification.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 damaged on the cannula.All samples passed.(b)(4).

• Brand Name: MCKESSON PREVENT ® HT SYRINGES WITH SAFETY HYPODERMIC NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14280659
• Report Number: 3003902955-2022-00012
• Device Sequence Number: 4874631
• Product Code: MEG
• UDI-Device Identifier: 30612479179098
• UDI-Public: 30612479179098
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 102-SN3C2558S
• Device Lot Number: 210511D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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