CONSOLIDATED MEDICAL EQUIPMENT COMPANY POOLE INSTRUMENT W/3.05 MTR TUBING 20/CS; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Model Number 0035070 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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One 0035070 returned unopened in original packaging.The lot number of the device - 202008055 was verified.The device encroached into the seal on the packaging.The device was dye leak tested which indicated that the packaging had an insufficient heat seal, the dye leaked into the gap in the seal caused by the device encroaching.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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During incoming inspection, the distributor rejected this device, 0035070, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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