MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON PREVENT® HT SYRINGES WITH SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Based on our investigation, the root cause of the problem could not be identified.The condition of the actual sample was not confirmed since it was not returned for evaluation.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 safety sheath was successfully activated without any difficulty 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.(b)(4).
Event or Problem Description
The user facility reported a component retention issue with the hypodermic needle.The medical assistant stated that she had experienced difficulty using the safety feature on the reported product.She stated it would not push into the safety as it was supposed to when activating.The difficulty was specifically activating the safety feature using both, a table top and with her finger.No needle sticks occurred due to this issue, and no patients were affected by the issue post injection.

• Brand Name: MCKESSON PREVENT® HT SYRINGES WITH 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: 8830661
• Report Number: 3003902955-2019-00033
• Device Sequence Number: 2536663
• Product Code: MEG
• UDI-Device Identifier: 30612479180650
• UDI-Public: 30612479180650
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 102-SNT1C2558S
• Device Lot Number: 190104D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1