C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0605510CE |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/01/2022 |
Event Type
Injury
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Event Description
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It was reported that one month and seventeen days post port placement, the device allegedly leaked around the chamber.It was further reported that, upon x-ray the catheter was allegedly fractured.Reportedly, the catheter and port were removed on later days.The current status of the patient is unknown.
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Manufacturer Narrative
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The catalog number identified in has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified in common device name and pma/510k.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: 02/2026).The information provide 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.Device not returned.
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Event Description
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It was reported that one month and seventeen days post port placement, the device allegedly leaked around the chamber.It was further reported that, upon x-ray the catheter was allegedly fractured.Reportedly, the catheter and port were removed on later days.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: this supplemental mdr is being submitted to report that mfr rpt# 3006260740-2022-03478 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 3006260740-2022-02991.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, chronoflex single-lumen, kit, 6f products are identified in d2 and g4.H10: d4 (expiry date: 02/2026), g3.H11: section a through f ¿ the information provide 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.
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