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 Problems
Suction Problem (2170); Blocked Connection (2888)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported blocked connection and suction issues, as no objective evidence was provided for review.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.(expiry date: 02/2021).
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Event Description
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It was reported that post port placement procedure, the hcp was allegedly had trouble in accessing the port.It was further reported that patient allegedly had pain and soreness.Reportedly, port allegedly unable to get blood return.The current status of the patient is unknown.
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Search Alerts/Recalls
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