C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1829500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Swelling/ Edema (4577)
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Event Date 05/03/2019 |
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 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.
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Event Description
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It was reported through the results of a clinical trial, that approximately ten days post port placement procedure, ecchymosis on breast, bruising and swelling around the port was observed.The current status of the patient was not provided.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation, one complaint report form was provided for review.The investigation is confirmed for the reported bruise and swelling issue.According to the complaint report form, approximately one week post port deployment, the patient experienced an adverse event of ecchymosis on breast and bruising and swelling around the port.The adverse event doesn¿t result in surgical re-intervention and recovered.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: 06/2020), g3, h6(method).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 through the results of a clinical trial, that approximately ten days post port placement procedure, bruising and swelling around the port was observed.The current status of the subject was not provided.
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Search Alerts/Recalls
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