Model Number MR170126024S |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/01/2022 |
Event Type
malfunction
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Event Description
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A hole was noted in the white lumen.The hole is between the catheter lumen and catheter wing.Catecholmine therapy could not be adequately administered and the patient showed increasing signs of heart failure.
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Manufacturer Narrative
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We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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One 2.6f double lumen vascu-picc was returned for evaluation.The lumen length is 50 cm indicating the lumen has not been trimmed.A functional examination was performed by flushing each lumen with water using a 10cc syringe.When flushing the lumen with the white clamp, a leak was noted at just proximal to the 24cm mark.Under magnification the damage to the lumen appears to be "v" shaped.When flushing the lumen with the red clamp, no leaks were noted.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.We are unable to determine the cause or factors that may have contributed to this event.
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Search Alerts/Recalls
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