Catalog Number 11012T |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states "there is a plastic seal inside the device - inside the co2 port.The customer breached the seal and pushed it down - now visible to the eye".This defect was found prior to patient use, no patient involvement.
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Manufacturer Narrative
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(b)(4).The complaint sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "the sample was closely examined by visual inspection and there was no abnormality found on the product.Complaint reported that there is plastic seal inside the device, but customer has breached the seal and pushed it down.Based on the investigation conducted on the returned sample, there is no plastic seal found in the device.Process will be conducted in our manufacturing site for the product after receiving the part item from supplier.Based on the investigation conducted, this complaint is not confirmed since no defect found on the returned sample.There is complaint with similar defect has been reported.The mentioned product housing was supplied by our supplier, and hence supplier corrective action request (scar) and nc has been issued and root cause analysis and identified corrective actions will be implemented through this scar.".Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states "there is a plastic seal inside the device - inside the co2 port.The customer breached the seal and pushed it down - now visible to the eye".This defect was found prior to patient use, no patient involvement.
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Search Alerts/Recalls
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