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 5829502 |
Device Problems
Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bruise/Contusion (1754)
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Event Date 03/25/2021 |
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 record is currently being 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: 05/2022).
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Event Description
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It was reported that some time post port placement, the port allegedly would rise when flushed and bruising was found around the site.It was further reported that the port was removed.Patient current status was unknown.
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Event Description
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It was reported that some time post port placement, the port allegedly would rise when flushed and bruising was found around the site.It was further reported that the port was removed and replaced.Patient current status was unknown.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.One photo were provided for review.Therefore, the investigation is confirmed for the reported septum dislodgement as one of the lumen was protruding the powerport in the provided photo.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.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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Search Alerts/Recalls
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