Catalog Number 306595 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a040101 ¿ fracture.
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Event Description
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2023.10.18 patient's postoperative catheter closure was performed using a prefilled catheter flosser, which was used normally.No other devices were used at the same time.During use, a crack was found at the needle stem and fluid was spilled, which was immediately replaced and used normally.
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Event Description
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(b)(4) follow up, on (b)(6) 2023 patient's postoperative catheter closure was performed using a prefilled catheter flosser, which was used normally.No other devices were used at the same time.During use, a crack was found at the needle stem and fluid was spilled, which was immediately replaced and used normally.
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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 306595 and lot number 2227182.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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Search Alerts/Recalls
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