BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1808050 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Inflammation (1932); Pain (1994); Swollen Glands (2092)
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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.(expiration date:08/2021).
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Event Description
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It was reported that post port device implant, the patient allegedly experienced bruise, swelling, pain and developed red spot around the port implant area.The patient status is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number.A device history record review is not required.Investigation summary: the investigation is inconclusive for the reported bruise, swelling, pain and red spot around the port implant area, as the device was not returned for evaluation.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 post port device implant, the patient allegedly experienced bruise, swelling, pain and developed red spot around the port implant area.The patient status is unknown.
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Search Alerts/Recalls
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