BARD ACCESS SYSTEMS POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVSCULAR
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Model Number 1718000 |
Device Problems
Obstruction of Flow (2423); Material Deformation (2976); Appropriate Term/Code Not Available (3191)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (08/2020).
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Event Description
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It was reported that post port placement, the patient allegedly experienced pain along the catheter track and inflammation in the neck.It was further reported that the catheter has compression at the clavicle.Reportedly, the port only works when the patient lays down.
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Event Description
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It was reported that post port placement, the patient allegedly experienced pain along the catheter track and inflammation in the neck.It was further reported that the catheter has compression at the clavicle.Reportedly, the port only works when the patient lays down.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the investigation is inconclusive for the reported catheter compression and swelling issue, as the device was not returned for evaluation.Based upon the available information, the 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 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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