MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Operator of device - unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Based on the results of our investigation the root cause of the complaint could not be identified related to our product or process.The actual sample was not returned for evaluation hence we could not provide detailed information of its actual condition.Retention samples were visually inspected and confirmed free from a bent cannula and defects that will affect activation of safety sheath such as missing tooth, tooth flash, short shot, flash on the sheath, over or under insertion, sheath collar-fitting, and damaged parts that will lead to the complaint.A simulation was also conducted thru aspiration of sterile water, injection to the dummy arm, and manual sheath activation wherein no bending of the needle was encountered that may result in needlestick injury.Lot history files showed no nonconformity or irregularity encountered during the production of the lot.We also have a series of visual in-process inspections from the molding until the boxing process to detect an abnormality on the sheath and collar such as crack, short shot, tooth flash, missing tooth, and damages that may lead to the complaint.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Functional tests through safety sheath activation were conducted to confirm that our products are free of defects that would lead to difficulty or failure of device activation.No nonconformity was noted.Furthermore, proper instruction for the usage of the sg2 safety needle device activation including warnings to avoid needle sticks is fully addressed in the instructions for use (ifu) indicated on the unit box.(b)(4).
Event or Problem Description
The user facility reported that the needle was flimsy.The staff incurred a needle stick because the needle was difficult to put into the vial.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE 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: 12822208
• Report Number: 3003902955-2021-00057
• Device Sequence Number: 20237801
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 102-N251S
• Device Lot Number: 201211B
• 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: 10/21/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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 Sex: Unknown