BARD ACCESS SYSTEMS POWERPORT TI SLIM, 6 FR CHRONO, W/SUTURE PLUGS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1716000 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Erythema (1840); Local Reaction (2035); Skin Erosion (2075)
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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.Expiry date (09/2020).
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Event Description
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It was reported that the sometime post port device implant, the patient allegedly experienced redness, scaling, and skin erosion.The patient status 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: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged redness, skin erosion to port issue due to the fact that no sample was returned for evaluation.However, a definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d4 expiry date (09/2020),g4 h11: b5,d1,d2,h6(device) 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 the sometime post port device implant, the patient allegedly experienced redness and skin erosion.The patient status is unknown.
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Search Alerts/Recalls
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