C.R. BARD, INC. (BASD) -3006260740 TITANIUM DOME IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 0602850 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/15/2021 |
Event Type
Injury
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Event Description
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It was reported that some time post port placement procedure, a chest x-ray examination was performed and demonstrated that stylet was allegedly left in the catheter inside the patient.It was further reported that additional interventional was required to remove the stylet.Patient current status was unknown.
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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: 12/2024).
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Search Alerts/Recalls
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