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

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The user facility reported that the involved mckesson medi-pak performance safety hypodermic needle syringe detached from the needle and the needle had to be pulled out separately.This happened when a vaccine was being administered to a (b)(6) year old child, they were unable to activate the safety device until the third try because they did not have a nearby hard surface.Pediatrics patient was unaffected, and the health care professional was not harmed.Additional information was received on 05october021: there was no patient injury or needle sticks due the issue reported.Patient received the vaccine as intended.They used the same needle to aspirate the vaccine as it was injected into the patient.The outcome of the procedure was the needle was pulled out separately from syringe.

Manufacturer Narrative

Patient date of birth - born in (b)(6).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.The actual sample was not returned for evaluation hence we could not provide detailed information of its actual condition.Retention samples were visually confirmed free from defects that will affect activation of safety sheath and passed the functional evaluation for sheath activation and deactivation.We have 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 and needle sticks.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.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 following the instructions for use (ifu) for the proper usage of the sg2 needle indicated on the unit box where quick activation on the flat surface is advised.(b)(4).

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• MDR Report Key: 12699595
• MDR Text Key: 281500215
• Report Number: 3003902955-2021-00054
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479180650
• UDI-Public: 30612479180650
• Combination Product (y/n): N
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 102-SNT1C2558S
• Device Lot Number: 201124D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 23