C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, CHRONOFLEX, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 7480000 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2022 |
Event Type
malfunction
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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 is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 04/2024.
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Event Description
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It was reported that prior to a port placement procedure, the device allegedly contaminated with foreign material.The procedure was completed using another device.There was no patient contact.
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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: one unsealed vaccess ct powerport implantable port kit was returned for evaluation.Gross visual and microscopic evaluations were performed.Manufacturing site evaluation of the sample shows that there was foreign material in the puncture area of the port, a closer view showed that this contamination appeared to be a piece of hair that was embedded in the septum.The investigation is confirmed for the reported hair on the port issue as the material on top of the port septum was noted to be a small piece of hair.The root cause is determined to be manufacturing related.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 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 : see h10.
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Event Description
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It was reported that prior to a port placement procedure, the device allegedly contaminated with foreign material.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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