Model Number AF5140MB |
Device Problems
Break (1069); Device Damaged Prior to Use (2284); Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
No Answer Provided
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Manufacturer Narrative
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The material composition of the resus bag and the drawstring bag are too similar causing the two products to "stick" together when the user tries to remove the resus bag from the drawstring bag.A non-conformance has been opened to quarantine all of the unused drawstring bags and another non-conformance has been opened to performed a wholesale rework of resus bags which includes the replacement of the drawstring bags.
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Event Description
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The customer alleges "product was broken while being removed from the packaging.The packaging was sticky and the product was difficult to remove." no other details were provided and no patient injury/harm reported.
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Search Alerts/Recalls
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