Model Number 381312 |
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 01/13/2022 |
Event Type
malfunction
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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 that bd insyte¿ iv winged catheter contained foreign matter in the device cannula.The following information was provided by the initial reporter: " the nurse opened the package of the indwelling needle and found a floc in the front injection port of the indwelling needle".
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Manufacturer Narrative
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H6: investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.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.Based on the quality team's investigation, the root cause of this incident cannot be determined.
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Event Description
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It was reported that bd insyte¿ iv winged catheter contained foreign matter in the device cannula.The following information was provided by the initial reporter: "the nurse opened the package of the indwelling needle and found a floc in the front injection port of the indwelling needle".
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Search Alerts/Recalls
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