Catalog Number 383266 |
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 04/28/2022 |
Event Type
malfunction
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Event Description
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It was reported while using bd intima-ii 26gax0.56in mz slm npvc foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: in pediatrics, there is water drop in connector of the indwelling needle.
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd intima-ii 26gax0.56in mz slm npvc foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: in pediatrics, there is water drop in connector of the indwelling needle.
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 09-may-2022.H6: investigation summary: one defect sample was received by our quality team for evaluation.The sample returned was in an unopened package of lot 0140319.Fluid was observed inside the housing of the maxzero.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The fluid visible within the maxzero is consistent with the medical-grade silicone which is used as a lubricant in the maxzero products.The application of silicone is a closely regulated process and the weight of the silicone is checked at regular intervals during the manufacturing of the maxzero components.The evaluation of the biological and chemical data indicates that the component can be considered safe for clinical use.H3 other text : see h10.
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Search Alerts/Recalls
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