Model Number 100/870/080 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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It was reported, that the doctor in charge of the procedure felt that the balloon came with holes.It's unknown, if there was patient involvement or any injury.
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Manufacturer Narrative
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B3: date of event is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Manufacturer Narrative
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Other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One decontaminated device was received.No visual observations were noted.A functional inflation test was performed in which it was not possible to inflate the cuff as it was leaking from a tear in the cuff.The root cause was due to manufacturing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Corrective actions have been taken including initiation of quality alert, training of production, replacement of gauges and equipment with blunt versions, warning in manufacturing procedure and establishing better organization on affected workplace.
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Manufacturer Narrative
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Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.
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Search Alerts/Recalls
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