Model Number 383346 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2021 |
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 bd saf-t-intima" iv catheter safety system separated from the hub after placing it in the external jugular vein.The following information was provided by the initial reporter, translated from (b)(6) to english: "the mother delivered a baby safely at 8:00 on (b)(6) 2021.At 9:03, due to postpartum hemorrhage, a second vein access was needed to be established, so the external jugular vein access was opened.After successful catheteralization of the external jugular indwelling needle, the exposed part of the transparent catheter tube and the green butterfly part were accidentally separated during the removal of the needle." "indwelling position: left external jugular vein.Measures: pull out the problem catheter, replace the indwelling needle (other brands) and the indwelling part (hand and forearm), and reinsert the catheter without delaying the treatment.The woman was not harmed and is in good condition.".
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Manufacturer Narrative
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H6: investigation summary: our quality engineer inspected the 3 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.The components separated due to partial solvent within the tubing, which can be caused by manufacturing personnel not following proper procedures.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.A quality alert was generated to inform all manufacturing personnel of the failure to prevent reoccurrence.H3 other text : see h10.
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system separated from the hub after placing it in the external jugular vein.The following information was provided by the initial reporter, translated from chinese to english: "the mother delivered a baby safely at 8:00 on (b)(6) 2021.At 9:03, due to postpartum hemorrhage, a second vein access was needed to be established, so the external jugular vein access was opened.After successful catheteralization of the external jugular indwelling needle, the exposed part of the transparent catheter tube and the green butterfly part were accidentally separated during the removal of the needle." "1.Indwelling position: left external jugular vein.2.Measures: pull out the problem catheter, replace the indwelling needle (other brands) and the indwelling part (hand and forearm), and reinsert the catheter without delaying the treatment.3.The woman was not harmed and is in good condition.".
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Search Alerts/Recalls
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