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

Model Number N/A

Device Problems Activation Failure (3270); Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

Catalog number- potential part numbers 102-n231s & 102-n251s.Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Operator of device - unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number initial reporter name - additional reporter (b)(6).Health professional: unknown.Occupation - unknown.The actual device was not returned to the manufacturing facility for evaluation.Based on the results of our investigation, the root cause of the complaint could not be identified.Since actual sample was not returned for evaluation hence we could not determine the details of its actual condition.No lot history files and retention samples were checked since complaint lot number is unknown.The representative samples were successfully activated without any difficulty during simulation.An audible click was heard and the activated needle was visually confirmed wherein cannula is securely locked on the sheath tooth and no abnormality was noted.We have series of visual in-process inspection to detect abnormality on the sheath that may lead to problem during sheath activation.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 problem.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Prior shipment, qc conducts outgoing visual and sensory inspection to assure lots are in good quality.(b)(4).

Event Description

The user facility reported that they had an incident of a staff member using the safety needle who was accidentally stuck despite the needle guard.It was reported that the cap on mckesson safety needle was flimsy (bent side-to-side too easily) and sometimes appeared to "snap" into a locked position but has not locked.

• 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
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: theresa mussaw ; 950 elkton blvd.; elkton, md ; 2837866718
• MDR Report Key: 9732548
• MDR Text Key: 206141642
• Report Number: 3003902955-2020-00006
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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