MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON PREVENT ® HT SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: (b)(6).Health professional: requested, unknown.Reporter occupation: administrative coordinator.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 our evaluation.Retention samples were visually confirmed free from defects that will affect the activation of the safety sheath and passed the evaluation for sheath activation and deactivation.Also, no irregularity was encountered during the simulation of manual sheath activation that may lead to the complaint.We have a series of visual in-process inspections to detect an abnormality on the sheath that may lead to a problem during sheath activation.The molding condition of the components critical to the safety activation of the product is routinely checked to assure that no defects will be encountered that will lead to sheath activation problems.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.We have received four (4) complaints covering fy20 to fy22 (september 28, 2022), related to this issue where most of the problems are related to usage particularly due to improper activation of the device (not activating on the hard and flat surface in a quick and firm motion).Based on the investigation of individual complaints there was no attributable cause noted related to our product and production process.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior to shipment, qc conducts outgoing visual, sensory, and functional inspections to assure lots are of good quality.Therefore, we advise to follow the instructions for use (ifu) for the proper usage of the sg2 needle indicated on the unit box in which warnings to prevent needle stick, cautions, and precautions are also included.(b)(4).
Event or Problem Description
The user facility reported that the involved needle is very dangerous and hard to put the safety on.An associate almost incurred a needle stick.Additional information was received on 22 sept 2022: it was reported that the needle was new for the facility.Post- successful patient flu vaccine.The healthcare provider (hcp) had a near miss with the safety activation.The hcp was activating it on a hard surface, when the needle bent keeping it from activating, and did not get stuck.There was no heath impact to the actual patient or the hcp.

• Brand Name: MCKESSON PREVENT ® HT 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15626302
• Report Number: 3003902955-2022-00046
• Device Sequence Number: 14947036
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 102-N251S
• Device Lot Number: 210807B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2021
• 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: Female