C.R. BARD, INC. (BASD) -3006260740 POWERFLOW APHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F; PORT & CATHETER, IMPLANED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number A710962 |
Device Problems
Restricted Flow rate (1248); Obstruction of Flow (2423); Blocked Connection (2888)
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Patient Problem
Pain (1994)
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Event Date 09/25/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation, however, the image was provided for review.The investigation of the reported event is currently underway.Device not returned.
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Event Description
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It was reported that post port implant in the mid-sternum in the center of breasts, the patient allegedly had difficulty in accessing it.It was further reported that the patient allegedly experienced pain.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation, three medical images were provided for review.Each image has a different number or orientation of ports within the chest.The first image depicts only one port on the right chest, although only half of the chest is visualized.The second image shows two ports ¿ one on each side of the chest.The last image shows two ports each on the right chest.There are no details to the specifics of these changes.These ports appear appropriately positioned.The investigation is inconclusive for the reported blocked connection and restricted flow rate, as no further details were provided with the three images and it is unclear why the port placement is different in each of the images.A definitive root cause could not be determined.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 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.H3 other text : device not returned.
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Event Description
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It was reported that post port implant in the mid-sternum in the center of breasts, the patient allegedly had difficulty in accessing it.It was further reported that the patient allegedly experienced pain.The current status of the patient is unknown.
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Search Alerts/Recalls
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