C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 7707540 |
Device Problems
Contamination (1120); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2021 |
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 return of the sample is pending.The investigation of the reported event is currently underway.
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Event Description
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It was reported that during port placement procedure, the device allegedly had an air contamination during puncturing the vessel with the needle.There was no reported patient injury.
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Event Description
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It was reported that during port placement procedure, the device allegedly had an air contamination during puncturing the vessel with the needle.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one introducer needle was returned for evaluation.Visual and functional evaluations were performed.The investigation is confirmed for the reported fracture issue as multiple cracks were observed on the proximal needle hub.The needle was patent to infusion and aspiration and the needle did not fully aspirate water and air was noted within the syringe.However, the investigation is inconclusive for the reported air contamination issue as the exact circumstances at the time of the reported event are unknown and the sample evaluation results indicating difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.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.H3 other text : see h10.
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Search Alerts/Recalls
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