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); Entrapment of Device (1212); Material Separation (1562); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/27/2024 |
Event Type
Injury
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Event Description
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It was reported that sometime post a port placement, the patient allegedly experienced swelling around the port area while infusion.It was further reported that the catheter was allegedly found to be disconnected from the port upon x-ray examination and the catheter allegedly migrated to the right heart.It was also reported that the catheter was stuck in the heart and was unable to be removed.Reportedly, the catheter was removed at later stage in the operating room.Furthermore, separation of the catheter and the port at the place of fixation was allegedly noticed.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: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 pending return.
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Event Description
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It was reported that sometime post a port placement, the patient allegedly experienced swelling around the port area while infusion.It was further reported that the catheter was allegedly found to be disconnected from the port upon x-ray examination and the catheter allegedly migrated to the right heart.It was also reported that the catheter was stuck in the heart and was unable to be removed.Furthermore, separation of the catheter and the port at the place of fixation was allegedly noticed.Reportedly, the catheter was removed at later stage in the operating room and the port was removed as well.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: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported catheter disconnection, material separation, migration and entrapment issues as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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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