TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK
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Model Number N/A |
Device Problems
Malposition of Device (2616); Activation Problem (4042)
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Patient Problems
No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
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Event Date 12/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Implanted date: device was not implanted.Explanted date: device was not explanted.Reporter occupation - ma - clinical supervisor.The actual device was not returned to the manufacturing facility for evaluation.Based from the results of our investigation, the root cause of the complaint 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 similar to the complaint.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).
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Event Description
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The user facility reported that a nurse was giving vaccines and the needle bent and she was with poked with it.Additional information was received 03january2020: the hcp stated after giving the vaccine, during activation of safety, it missed the safety (tooth) and needle bent to the side of safety.She was stuck with needle protruding to the side, after handling the safety needle for disposal.Hcp was sent for blood work per facility protocol.Hcp was cleared, as testing was negative for bbp, and returned to facility.Vaccines being given were in pre-filled syringes with needle attached for injections.No impact on pediatric patient who received vaccines as intended.
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