SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA SUCTIONAID TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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Catalog Number 100/870/080CZ |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(udi) is unknown; no additional information was provided.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A review of the device history records (dhr) showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.One decontaminated product sample was received for investigation with its original packaging.Under visual inspection the sample appeared to be in good condition.The inflation test was repeated on the received sample.It was observed that it was not even possible to inflate the cuff because it leaked so badly.Then the sample was submerged into water and cuff was inflated.Air leak from cuff caused by 2mm long tear was identified.The root cause was deemed to be manufacturing-related.The affected batch was manufactured in february 2019.Since this time, several corrective actions have been implemented with purpose to reduce possibility of cuff damage after inflation test.
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Event Description
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It was reported that, during a pre-use check on the product, the cuff did not inflate; therefore, it was not used.No patient injury was reported.
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Search Alerts/Recalls
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