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Model Number M001182880 |
Device Problems
Fracture (1260); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that a catheter fracture occurred.A 135/10 renegade¿ hi-flo¿ was selected for use.During preparation, when withdrawing the catheter completely from the conditioning tube, it was noted that the proximal part near the hub of the renegade¿ was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a renegade hi flo micro catheter.The tip, markerband, proximal shaft, and distal shaft was microscopically and tactile inspected.Inspection revealed shaft damage (pinch) located 2.5 cm from the strain relief, and numerous kinks throughout the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.While the shaft was not fractured as reported, the damage may give the appearance of a fractured shaft when only observed with a naked eye.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
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Event Description
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It was reported that a catheter fracture occurred.A 135/10 renegade hi-flo was selected for use.During preparation, when withdrawing the catheter completely from the conditioning tube, it was noted that the proximal part near the hub of the renegade was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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