Model Number IPN048386 |
Device Problem
Fitting Problem (2183)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that "the hospital faced two incidents during a situation of emergency intubation procedure.The blade did not snap properly on the handle.The consequence was a lighting fault and a damage of the handle".No patient harm or injury reported.Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.
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Manufacturer Narrative
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(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.The manufacturing site reports that a visual exam was conducted on the photo and "it has been identified that the groove of the handle seems damaged/worn out and there could be possibilities that due damaged/worn-out groove customer has faced the issue of handle and blade." the device history record for lot code 1808331 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The ifu for this product states: "always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that "the hospital faced two incidents during a situation of emergency intubation procedure.The blade did not snap properly on the handle.The consequence was a lighting fault and a damage of the handle".No patient harm or injury reported.Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.
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Search Alerts/Recalls
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