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

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional - unknown.Occupation - unknown.The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon evaluation of user facility information, and evaluation of the retention sample.Based on the results of our investigation, the root cause of the complaint could not be identified since condition of the actual sample was not confirmed.Retention samples were visually in good condition and passed the cannula stiffness test.Moreover, no bent cannula was encountered during simulation.We have cannula guide chuck used to hold cannula while placing the needle assembly to the collar to prevent unnecessary movement that could damage the cannula.When the bevel orientation is correctly placed against the collar then the hub, cannula, and collar are pressed into the protector.If there is bent cannula, then protector cannot be placed into the needle.Lot history file showed no issued nonconformity related to the complaint.We have series of in-process inspection and qc outgoing inspection to check overall condition of the needles.(b)(4).

Event Description

The user facility reported that the needles are bending and protruding through the safety cap.The medical assistant was punctured by the needle through the cap.Additional information received on (b)(6) 2019: the needle bent and came through the safety cover, and went through the thumb of the medical assistant.The needles are very flimsy and are bending very easily.Additional information received on (b)(6) 2019: blood work was performed on the medical assistant and was negative.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the unused device return date in the d10 section, to update the h3 section and to provide the completed investigation results.Five unused received same lot samples were received for evaluation.The received same lot samples were visually confirmed and subjected to cannula stiffness test.No nonconformity was noted.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• MDR Report Key: 8289607
• MDR Text Key: 134509350
• Report Number: 3003902955-2019-00001
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• Combination Product (y/n): N
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 102-N251S
• Device Lot Number: 180413B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR