CARDINAL HEALTH 1.9 FR ARGYLE DUAL LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number 43304 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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Customer reports: during use the 1.9 french double lumen picc line noted to be cracked right next to the purple plastic stabilizer.There was no harm to the patient.A new line was required.There was no harm to the patient.A new line was required.Additional information provided by the customer on 2/10/22 clarified that a leak occurred just above the butterfly where the extension tubing meets the butterfly.
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Manufacturer Narrative
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The lot number was reported as unknown therefore a manufacturing device history record (dhr) review or product/process changes review for the reported lot number could not be assessed.In addition, all dhrs are reviewed to confirm all regulatory requirements prior to product release.One used catheter from an unknown lot number was received inside of a generic plastic bag for analysis and investigation.A visual inspection revealed that the catheter showed signs of use (such as residues of a white substance) and the catheter was broken just below the butterfly.Therefore, the event reported by the customer was confirmed.The physical sample evaluation did not detect a leak in the catheter.Based on the device being used, it is determined that the catheter was in good conditions prior use and the manufacturing process was reviewed and no potential causes contributing to the condition were found.The condition reported most likely occurred from not adhering to the ifu.According to a corrective/preventative action (capa) assessment, it has been determined that there is no capa related to the event reported in this complaint.No further actions are required as the reported condition was not confirmed as manufacturing related.
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Search Alerts/Recalls
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