C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1618000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Date 12/01/2022 |
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 is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2024).Device not returned.
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Event Description
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It was reported that sometimes post port placement procedure, the patient allegedly experienced inflammation around the port.It was further reported that patient experienced extreme pain after placement.Reportedly, antibiotics were given to treat skin breakdown.The current status of the patient is unknown.
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Event Description
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It was reported that sometimes post port placement procedure, the patient allegedly experienced inflammation around the port.It was further reported that patient experienced extreme pain after placement.Reportedly, antibiotic given to treat skin breakdown.The current status of the patient is 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 sample was not returned for evaluation.One electronic photo was provided for review.The photo shows the bruises like red marks and inflammation on the skin of the patient.However, the investigation is inconclusive for the reported inflammation and pain issue as it is unknown whether the red marks on the patient skin was caused by the device.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.The 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.H10: d4 (expiry date: 01/2024), 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.H3.
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