C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LEUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 9808560 |
Device Problems
Component Missing (2306); Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/25/2020 |
Event Type
malfunction
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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 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.Device not returned.
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Event Description
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It was reported that during a port placement, the lot seal was allegedly missing from the kit.There was no reported patient injury.
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Event Description
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It was reported that during a port placement, the barcode label was allegedly missing.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a complaint history review was performed.This is the fifth complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: one powerport mri isp and a carton label on the packaging box were returned for evaluation.Visual and microscopic visual evaluation were performed on the returned device.The carton label on the returned device was compared with the carton label in the jde.No anomalies were noted on the label upon reviewing.Therefore, the investigation is inconclusive for the reported missing information issue as no issues were noted on the returned carton label and the reported information are not by themselves sufficient to unconfirm the issue.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.
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Search Alerts/Recalls
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