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	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was giving a b-12 injection to a patient, and when the employee went to put the safety over the needle, the entire needle came off and stuck her.Additional information was received on 02december2021: it was reported that the needle came off of the syringe and stuck in her finger while she was trying to activate the safety.
Additional Manufacturer Narrative
Operator of device - unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter: occupation: owner.The root cause of the complaint could not be identified.The actual sample was not available for evaluation.The photo was provided wherein the involved sg2 safety needle was activated.However, the involved syringe was not included on the photo.Traces of blood on the hub was observed.Retention samples were visually confirmed free from defects that will affect activation of safety sheath and passed evaluation for sheath activation and deactivation.Also, the needle is fully engaged under the lock (sheath tooth) and no loose/detached needle from syringe or any irregularity during the simulation of manual sheath activation that may lead to the complaint.We have visual in-process inspections conducted during molding process, needle assembly, syringe assembly, manual-syringe needle assembly and boxing process to detect an abnormality on the sheath, needle, and syringe such as crack, short shot, hub melt, and any molding related defects that may lead to a loose/detached needle from syringe during sheath activation/deactivation.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts of sheath, needle, and syringe that will affect product function is being confirmed.No nonconformity was noted.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Before shipment, qc conducts outgoing visual, sensory, and functional inspections to assure lots are of good quality.We advise to follow the instructions for use (ifu) for the proper usage of the sg2 syringe indicated on the unit box in which warnings to prevent needle stick, cautions, and precautions are also included.(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: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13082363
• Report Number: 3003902955-2021-00067
• Device Sequence Number: 4696931
• Product Code: MEG
• UDI-Device Identifier: 30612479179098
• UDI-Public: 30612479179098
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2021

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 Expiration Date: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 102-SN3C2558S
• Device Lot Number: 201022D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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 Age: 34 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White