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Catalog Number 306594 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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On (b)(6) 2024, a nurse used a prefilled catheter irrigator to flush an indwelling needle catheter for a patient, and found that its outer packaging was damaged and the push rod handle was broken.Then replace the washer with a new one.
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Manufacturer Narrative
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(b)(4) follow up it was reported the outer packaging was damaged and the push rod handle was broken.As a sample was not returned, a thorough sample investigation could not be performed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a syringe in its packaging flow wrap.The syringe plunger rod thumb press and the packaging flow wrap are damaged.No other defects or imperfections were observed.This defect could occur if the syringe was not placed in the correct location on the conveyor inducing the damage.A device history record review was completed for provided material number 306594, lot 3297902.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the flow wrap process was performed.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.
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Event Description
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No additional information received.On (b)(6) 2024, a nurse used a prefilled catheter irrigator to flush an indwelling needle catheter for a patient, and found that its outer packaging was damaged and the push rod handle was broken.Then replace the washer with a new one.
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Search Alerts/Recalls
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