NULL PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Lot Number 4115553 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Visual inspection: the sample was visually inspected: results: sample present a pin hole on the breathing bag.Conclusions: failure mode reported as pinhole is confirmed on the breathing bags.Root cause: the event description provided it by the customer: "during the pre-use check, the customer found a pin hole in the breathing bag." base on the investigation results there is pin holes on the raw material breathing bag provided by the supplier.Action taken: the following action were taken: corrective actions will be addressed and implemented trough supply notification (b)(4) - (b)(6) 2021 / status - scar acknowledge.Secondary investigation was open it (b)(4) - (b)(6) 2021 dhr: the lot 4115553 was manufactured with (b)(4) units, lot met the requirements to release the lot with no deviations identified during their manufactured.
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Event Description
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It was reported that during the pre-use check, the customer found a pinhole in the breathing bag.No patient injury was reported.
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Search Alerts/Recalls
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