C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 7707540J |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified in section has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products are identified in common device name and pma/510 k.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2024).
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Event Description
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It was reported that one month and five days post port placement via the left internal jugular vein, the catheter lumen was found to be narrowed due to movement of the patient's neck.It was reported that the patient complained of neck pain due to medicine leakage while using the port system.Reportedly, the port system was removed and leakage from the catheter was found after removal the port system.The procedure will be completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one x-port isp mri implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic visual, tactile evaluation and functional testing were performed.The investigation is confirmed for the reported fluid leak and identified material puncture/hole issues as two pin holes, in-parallel, were noted on the attached catheter.Upon infusion, leaks were observed throughout the attached catheter, aspiration was attempted and was unsuccessful.A definitive root cause could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 01/2024), g3, h6 (device, method).H11: h6 (result, conclusion).H11: section a through f - the information provided by bd represents all of 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 : see h10.
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Event Description
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It was reported that one month and five days post port placement via the left internal jugular vein, the catheter lumen was found to be narrowed due to movement of the patient's neck.It was reported that the patient complained of neck pain due to medicine leakage while using the port system.Reportedly, the port system was removed and leakage from the catheter was found after removal of the port system.The procedure will be completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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