Catalog Number 307865 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the needle pulled loose from the bd luer-lock¿ safety syringe hub after aspirating medication.The following information was provided by the initial reporter, translated from portuguese: "the nursing technician aspirated the immunobiological agent using the correct technique, and before applying it, noticed that the needle had come loose from the base (03 ml syringe/ 0.55x 20mm needle).Batch: 0195152 there was no harm to the patient".
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Manufacturer Narrative
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H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
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Event Description
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It was reported that the needle pulled loose from the bd luer-lock¿ safety syringe hub after aspirating medication.The following information was provided by the initial reporter, translated from portuguese: "the nursing technician aspirated the immunobiological agent using the correct technique, and before applying it, noticed that the needle had come loose from the base (03 ml syringe/ 0.55x 20mm needle).Batch: 0195152 there was no harm to the patient".
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Search Alerts/Recalls
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