C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 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 Problem
Embolism/Embolus (4438)
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Event Date 08/13/2021 |
Event Type
Injury
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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 records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 12/2021).Device pending return.
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Event Description
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It was reported that post port device implant, the catheter was allegedly found to be broken and embolized into the right atrium.The current status of the patient is good.
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Event Description
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It was reported that post port device implant, the catheter was allegedly found to be broken and embolized into the right atrium.Reportedly, surgery was performed to remove the device from the patient body.The patient was reportedly stable.
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Manufacturer Narrative
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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 catheter fracture and migration issues, as no objective evidence was provided for review.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.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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Manufacturer Narrative
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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 groshong catheter segment was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture and the identified material separation issues, as a complete circumferential break was noted approximately 17.4 cm from the distal tip of the catheter and the surface of the complete circumferential break was noted to be granular and uneven.The investigation is inconclusive for the reported migration issue, as the exact circumstances at the time of the reported event are unknown, and the reported event could not be reproduced in the lab.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: 02/2023), g3, h6 (device).H11: d4 (medical device lot number), h6 (method, result).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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Event Description
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It was reported that post port device implant, the catheter was allegedly found to be broken and embolized into the right atrium.Reportedly, surgery was performed to remove the device from the patient body.The patient was reportedly stable.
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Search Alerts/Recalls
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