Model Number IPN922772 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that as the doctor "was placing the lma in the patient's airway, the silicone cuff came apart from the plastic tube and then got lodged in the patient's airway.The doctor was able to pull it out safely".Additional information states that there was no patient harm or injury, the patient status is reported as "fine".The procedure was completed with minimal delay and the patient did not experience any oxygen desaturation.The device was brand new with no noticeable damages.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed on the returned device and it was observed that the backplate was detached.The presence of glue was noticed on the joint area of the tube and the backplate joint area.It was also reported that "dhr for the packaging lot 11f22k0418 was reviewed and no abnormalities was found with the complaint lot.No findings or reject on different size of product was observed during the packaging process." the complaint was confirmed based on the visual exam of the returned sample.The root cause is manufacturing related.
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Event Description
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It was reported that as the doctor "was placing the lma in the patient's airway, the silicone cuff came apart from the plastic tube and then got lodged in the patient's airway.The doctor was able to pull it out safely".Additional information states that there was no patient harm or injury, the patient status is reported as "fine".The procedure was completed with minimal delay and the patient did not experience any oxygen desaturation.The device was brand new with no noticeable damages.
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Search Alerts/Recalls
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