Catalog Number 306594 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Pr 9747084: initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
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Event Description
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(b)(6) 2024 10:00 while preparing to seal the patient's catheter, the nurse discovered that the piston of the pre-filled catheter had dislodged, and was given an immediate replacement pre-filled catheter flusher with no adverse consequences to the patient.
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Manufacturer Narrative
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(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 3178586.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
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Event Description
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No additional information received.On (b)(6) 2024 10:00 while preparing to seal the patient's catheter, the nurse discovered that the piston of the pre-filled catheter had dislodged, and was given an immediate replacement pre-filled catheter flusher with no adverse consequences to the patient.
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Search Alerts/Recalls
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