Catalog Number 400273 |
Device Problems
Material Fragmentation (1261); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2023 |
Event Type
malfunction
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Event Description
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Customer was using perisafe kit, in procedure customer try to retract catheter ,initially it was getting streached and later it got broken inside.Customer has not shared the physical sample, only shared defects in photo.2) as per customer there is no harm to patient/caregiver.3) no.4) during the use.5) no, they have discarded the sample.6) no details shared by the customer.7) this customer is using this product ( perisafe-400273) since 8-10 years, he never faced such issues earlier , so he is also curious why this happened ??? is there any change happened in product materials or is this issue with this batch stocks only.
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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.Device problem code: a040103 - material fragmentation patient problem code: f26 ¿ no health consequences or impact.
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Manufacturer Narrative
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Two photos received by our quality team for investigation.Through visual inspection, it is observed an epidural catheter in which the front end of the catheter seems stretched and broken (torn).Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.It is important to follow instructions for this product, to avoid damage to the catheter, do not withdraw the catheter through the needle once the catheter has passed beyond the epidural needle tip.Also, in the caution section indicates: do not withdraw catheter through needle.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
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Event Description
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Additional information received.Customer was using perisafe kit, in procedure customer try to retract catheter, initially it was getting stretched and later it got broken inside.Status of physical sample details if sample was shipped, please share the tracking details.Was there any harm to the patient/caregiver? (detail).Was there exposure to blood or chemotherapy to mucous membranes or skin? (detail).Was the reported incident noticed before, during or after use? is sample available? if yes, please ship.Was there a need for medical and/or surgical intervention due to the incident (imaging tests, surgery, medication administration, etc.)? (detail).Provide any additional details.Customer has not shared the physical sample, only shared defects in photo.As per customer there is no harm to patient/caregiver.No.During the use.No, they have discarded the sample.No details shared by the customer.This customer is using this product (perisafe-400273) since 8-10 years, he never faced such issues earlier, so he is also curious why this happened? is there any change happened in product materials or is this issue with this batch stocks only?.
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Search Alerts/Recalls
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