Catalog Number CV-15703 |
Device Problem
Cut In Material (2454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports while the bandage was re-done by the nurse, it was discovered that the proximal line of the central catheter was almost cut.The catheter was inserted few days before and no damage was noticed when it was inserted.The customer alleges there was no a cut instrument nearby.No clinical consequences reported.
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Manufacturer Narrative
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(b)(4).The customer returned one used 3-lumen cvc for evaluation.The proximal extension line was separated three-quarters of the way down.The separation surfaces were microscopically examined and found to be smooth and uniform, indicating the extension line came into contact with a sharp object.No lot number was provided, but a device history record review was performed based on a potential lot number and no relevant findings were identified.The instructions-for-use (ifu) that are packaged with this product cautions to only use the indicated securement points when securing the catheter to the patient and not to suture directly to the outside diameter of the catheter.The customer reported issue of the extension line becoming separated during used was confirmed during the sample investigation.Visual examination was performed and the proximal extension line was found to have been cut by a sharp object.Based on the information provided and the condition of the returned sample the probable cause of this issue is operational context.No further action shall be taken at this time.
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Event Description
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The customer reports while the bandage was re-done by the nurse, it was discovered that the proximal line of the central catheter was almost cut.The catheter was inserted few days before and no damage was noticed when it was inserted.The customer alleges there was no a cut instrument nearby.No clinical consequences reported.
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Search Alerts/Recalls
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