C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM TI W 6FR CHRONOFLEX WO SP, INTER. KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1716001 |
Device Problems
Difficult to Flush (1251); Device Appears to Trigger Rejection (1524); Difficult to Remove (1528); Suction Problem (2170)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/15/2023 |
Event Type
Injury
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Event Description
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It was reported that sometimes post port placement procedure, the catheter was allegedly difficult to flush, had to use extra force and did not provide a blood return.It was further reported that a dye study was performed, and fibrin sheath was noted.It was further reported that the port was too attached to the chest wall and cannot be removed.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: 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.H10: d4 (expiry date: 03/2020) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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Search Alerts/Recalls
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