MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE 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	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.Retention samples were confirmed free from defects that will affect activation of safety sheath.Related functional testing such as sheath activation and deactivation were all passed.In addition, the sheath was successfully activated without any difficulty and no bending of cannula was encountered during simulation.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.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior shipment, qc conducts outgoing visual, sensory, and functional inspection to assure lots are in good quality.All samples passed.
Event or Problem Description
The user facility reported that after immunization, the nurse was doing the safety mechanism and stuck herself.The needle was bent.Additional information was received june 28, 2019: the nurse had activated the safety, and when she picked up the needle to dispose she was stuck.She then noted the needle had not been activated and was bent.The needle was not bent prior to activation.The patient received immunization as intended and was not affected.The nurse was sent for blood work and was cleared to return to work.The patient being treated was negative for infectious disease.

• 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
• MDR Report Key: 8808456
• Report Number: 3003902955-2019-00032
• Device Sequence Number: 18913791
• Product Code: MEG
• UDI-Device Identifier: 30612479178824
• UDI-Public: 30612479178824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 102-N2558S
• Device Lot Number: 180703B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1