COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
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Model Number N/A |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: supervisor.Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It was reported an ultrathane mac-loc locking loop multipurpose drainage set was used for a trans-gluteal abscess drainage procedure.As reported, "when placed, they (operator) weren't able to draw anything out of the catheter." the procedure was then completed with a replacement device of the same type.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Manufacturer Narrative
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Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation, this event is not reportable.There is no information confirming device malfunction or serious injury.Replacement of device to complete procedure is negligible harm and does not meet the criteria for a reportable event.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.
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Event Description
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See h10.
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