C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603870CE |
Device Problems
Disconnection (1171); Fracture (1260); Migration (4003)
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Patient Problems
Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us, but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products is identified.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: 06/2024).Device not returned.
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Event Description
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It was reported that approximately one year post port placement, the catheter allegedly fractured and migrated to the heart.Reportedly, intervention was required for the removal of catheter.The current status of the patient is unknown.
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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 m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products is 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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.The definitive root cause could not be determined based upon available 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: b2, d4 (expiry date: 06/2024), g3, h6 (method).H11: b5, e1, e3, h6 (patient).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 : device not returned.
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Event Description
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It was reported that approximately ten months post port placement, the catheter allegedly fractured and migrated to the heart.It was further reported that the device embolize in the patient.Reportedly, intervention was required for the removal of catheter.The current status of the patient is unknown.
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Search Alerts/Recalls
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