C.R. BARD, INC. (BASD) -3006260740 POWERPORT TI, 9.6FR. S/L SILICONE, INTERMEDIATE KIT W/ SUTURE PLUG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1709600 |
Device Problems
Blocked Connection (2888); Inadequate User Interface (2958); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Pain (1994)
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Event Date 03/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records will 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.(expiry date: 12/2016).Device not returned.
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Event Description
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It was reported that approximately 4 years 8 months post port placement, a ct scan demonstrated that the port was allegedly difficult to find bumps.It was further reported that the port was allegedly difficult to access.Reportedly the patient experienced pain as the port was going up into the neck and can hear the heart beat.The patient's condition was reported to be stable.
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Search Alerts/Recalls
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