C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 7707540 |
Device Problems
Fracture (1260); Material Separation (1562); Migration (4003)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.Expiry date: 09/2024.Device not returned.
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Event Description
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It was reported that approximately two months from post port placement, the catheter was allegedly fractured.It was further reported that the catheter was separated and migrated to right atrium of the heart.The current status of the patient is unknown.
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Event Description
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It was reported that two months from post port placement, the catheter was allegedly fractured.It was further reported that the catheter was separated and migrated to right atrium of the heart.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.However, one image was provided for review.The investigation is confirmed for the reported catheter fracture, material separation and migration issues as in the image the catheter is in the internal jugular extending into the right atrium.A definitive root cause could not be determined based upon the 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: d4 (expiry date: 09/2024).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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Search Alerts/Recalls
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