Model Number 381234 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 catheter 20ga 1.16in separated after placement and had flashback.The following information was provided by the initial reporter: "after the device has been placed, there was not blood reflux.Removing the device they saw there was the distal part of the catheter missing (0,5 cm) and the catheter was damaged.The missing part has been detected by echography in the soft tissue.Patient has a surgical consultation but it was decided not to remove the broken part because it is inert in the soft tissue.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/14/2020.H.6.Investigation: one representative sample was received by our quality team for evaluation.The sample was subjected to visual inspection and flashback testing.No abnormality was observed; therefore, the incident could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Due to no abnormality observed during investigation, a root cause could not be determined.
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Event Description
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It was reported that bd insyte¿ iv catheter 20ga 1.16in separated after placement and had flashback.The following information was provided by the initial reporter: "after the device has been placed, there was not blood reflux.Removing the device they saw there was the distal part of the catheter missing (0,5 cm) and the catheter was damaged.The missing part has been detected by echography in the soft tissue.Patient has a surgical consultation but it was decided not to remove the broken part because it is inert in the soft tissue.".
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Search Alerts/Recalls
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