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Catalog Number 0600540CE |
Device Problems
Expulsion (2933); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified has not been cleared in the us but is similar to the broviac cv catheter, single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the broviac cv catheter, single-lumen, 6.6f products are identified.Device not returned.
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Event Description
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It was reported that post chronic catheter implant, the cuff of the device was allegedly exposed.It was further reported that the catheter was dislodged.The current status of the patient is unknown.
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified has not been cleared in the us but is similar to the broviac cv catheter, single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the broviac cv catheter, single-lumen, 6.6f products are identified.Device not returned.
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Event Description
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It was reported that post chronic catheter implant, the cuff of the device was allegedly exposed.It was further reported that the catheter was dislodged.The current status of the patient is unknown.
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Search Alerts/Recalls
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