C.R. BARD, INC. (BASD) -3006260740 INTL POWERPORT TI, 8FR, CHRONOFLEX INT WSP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8708000 |
Device Problem
Expulsion (2933)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/27/2022 |
Event Type
Injury
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Event Description
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It was reported that port placement procedure, the port was allegedly exposed through skin.It was further reported that the port was removed.The procedure was completed using another device.Patient was reportedly stabilized.
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be 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.
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Event Description
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It was reported that sometime post port placement procedure, the port was allegedly exposed through skin.It was further reported that the port was removed.The procedure was completed using another device.Patient current status was stable.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.Therefore, the investigation is inconclusive for the reported skin erosion as the issue occurred in the clinical conditions cannot be confirmed based on the provided photo.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: b5, g3, h6 (method).H11: h6 (result, conclusion).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 other text : device not returned.
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