SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; TUBE, TRACHEAL (W/WO CONNECTOR)
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Model Number 101/860/070CZ |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2021 |
Event Type
malfunction
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Event Description
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It was reported that during the pre-use check, leakage of air from the product was observed.Also, the cuff was unable to be inflated.There was no patient injury reported.
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Manufacturer Narrative
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This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.One decontaminated sample was received for investigation without its original packaging.Visual inspection confirmed that there was tear in the cuff.During the functional testing it was observed that it was not even possible to inflate the cuff because it leaked so badly.The most probable root cause of this defect occurred during manufacturing or packaging of this device, due to fact that cuff leak was detected by customer during pre-use check.No further action was taken.
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Search Alerts/Recalls
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