BARD ACCESS SYSTEMS POWERPORT ISP MRI 6F CHRONOW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806061 |
Device Problems
Fracture (1260); Suction Problem (2170); Obstruction of Flow (2423)
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Patient Problems
Swelling (2091); Discomfort (2330)
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Event Date 07/30/2020 |
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; however, photo was provided for review.The investigation of the reported event is currently underway.Expiry date (03/2021).
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Event Description
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It was reported that approximately seven months post port placement in the right internal jugular vein, the catheter was allegedly unable to obtain a blood return.It was further reported that a bulge and redness was identified on the neck while injecting saline into the port.The patient reportedly experienced discomfort.Reportedly, an x-ray was performed, the catheter was found broken, and the port was removed.The patient status was unknown.
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Manufacturer Narrative
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H10: manufacturing review:the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation, however, one electronic photo was provided for review.The investigation is inconclusive for the reported catheter rupture and suction problem as the exact circumstances at the time of the reported event are unknown, and the reported event could not be confirmed from the provided photos.A 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.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.
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Event Description
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It was reported that approximately seven months post port placement in the right internal jugular vein, the catheter was allegedly unable to obtain a blood return.It was further reported that a bulge and redness was identified on the neck while injecting saline into the port.The patient reportedly experienced discomfort.Reportedly, an x-ray was performed, the catheter was found broken, and the port was removed.The patient status was unknown.
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Search Alerts/Recalls
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