SMITHS MEDICAL ASD, INC. PORTEX TRACHEOSTOMY REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Model Number 526070 |
Device Problems
Accessory Incompatible (1004); Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Related to mfrs (same patient, multiple cannula issues): 3012307300-2019-02852, 3012307300-2019-02854, 3012307300-2019-03577, 3012307300-2019-03578, 3012307300-2019-03579, 3012307300-2019-03580, 3012307300-2019-03581, 3012307300-2019-03582, 3012307300-2019-03583, 3012307300-2019-03584, 3012307300-2019-03585, 3012307300-2019-03587, 3012307300-2019-03588.Reporter: reporter stated they are a retired pediatric tracheostomy and ventilator nurse specialist.
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Event Description
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Information was received that a smiths medical portex tracheostomy replacement inner cannula would not latch into place immediately upon use.It was noted that the patient's daughter is a certified pediatric nurse and "she helped her out" at the time of the event.The reporter also stated the patient's tracheostomy tube "is changed monthly at doctor's order.We did not have to change it due to the cannula not snapping.The cannula was changed twice a day to decrease risk of infections and to maintain patency of the airway".Four routine tube change outs were completed since the start of the event to present time ((b)(6)).The daughter reported they had the same problem of the cannulas not snapping even with a new tube.Subsequently, due to the reporter noting the patient had run low on a supply of cannulas, some cannulas had to be cleaned, boiled, and re-used.There were no adverse patient effects as a result of the event.
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Manufacturer Narrative
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Fourteen tracheostomy tubes were received for evaluation; seven samples were received in used condition, and seven in new condition.Visual inspection of the samples found them to be in good physical condition.Seven inner cannulas were inspected, and all were in specification, no discrepancies were found.Manufacturing was reviewed; line clearance record of inner cannula and the packaging process.Prior to packaging, a sample of 32 units was taken, in order to perform a visual inspection to verify for any damage with the inner cannula.No discrepancies were noted.The customer's reported complaint was unable to be confirmed.
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