COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
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Catalog Number ULT10.2-38-40-P-32S-CLB-RH |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
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Event Description
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The complainant reported that the device was being used as a chest tube drain; the hub came off of the drain so the device was exchanged.There were no reports of any section of the device remaining inside the patient's body or any additional procedures as a result of this product problem.Additionally, the initial reporter noted that the patient did not experience any adverse effects as a result of this product problem.
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Search Alerts/Recalls
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