C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1808060 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
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Event Date 02/23/2021 |
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 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.(expiry date: 05/2015).
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Event Description
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It was reported that after one year of port placement the patient allegedly experienced deep itching around the port area.Patient current 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 product/lot number combination.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation is inconclusive for the reported deep itching issue, as the device was not returned for evaluation.Although a definitive root cause could not be determined, the following contributing factors allergies to materials, improper placement technique or patient anatomy or interactions between the implanted device and surrounding tissue could have potentially caused or contributed to the reported event.Based upon the available information a 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.H10: d4 (expiry date: 05/2015), b5, g3.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 after one year of port placement the patient allegedly experienced deep itching around the port area.It was also reported that the patient allegedly experienced dermal reaction when tegaderm was applied.Patient current status is unknown.
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Search Alerts/Recalls
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