Model Number 381423 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Fever (1858); Vomiting (2144)
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Event Date 10/21/2020 |
Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter caused the patient's vein to blow, and would not come out until vat was called to remove it.Upon removal, a "slit/puncture" was found in the catheter, and the patient required additional needle procedure for another iv placement.The following information was provided by the initial reporter: "rn went to place iv in patient's left ac, retracted needle and obtained cultures.Vein blew and when this rn went to remove iv catheter, it would not come out.This rn never rethreaded needle into the catheter.Vat called to bedside and removed catheter from patient.When catheter was removed, it has a slit/puncture in it.Catheter and packaging was bagged.Patient and family updated through entire process." "yes, patient required additional needle procedure for iv placement" "causing fever and vomiting.".
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Manufacturer Narrative
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H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received a catheter adapter assembly attached to miscellaneous tubing.Before decontamination, media was present throughout the catheter and extension tubing indicating that venipuncture did occur.Through the microscopic examination the unit revealed skiving and a v-shaped hole near the tip of the catheter which indicates that the cannula tip had scratched and pierced the catheter wall confirming damage to the catheter.This defect can occur during the manufacturing process or during use of the product.Typically, if this occurs during the manufacturing process a more well defined v-shaped cut is present and would be very noticeable upon unpacking in the user environment.Then if venipuncture was attempted, it would be very problematic.Based on the evidence and report that venipuncture did occur, the more likely cause is the catheter damage occurred during use.This can occur if the cannula is moved up and down within the catheter tubing while attempting venipuncture.A device history record review showed no non-conformances associated with this issue during the production of this batch.See h.10.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter caused the patient's vein to blow and would not come out until vat was called to remove it.Upon removal, a "slit/puncture" was found in the catheter, and the patient required additional needle procedure for another iv placement.The following information was provided by the initial reporter: "rn went to place iv in patient's left ac, retracted needle and obtained cultures.Vein blew and when this rn went to remove iv catheter, it would not come out.This rn never rethreaded needle into the catheter.Vat called to bedside and removed catheter from patient.When catheter was removed, it has a slit/puncture in it.Catheter and packaging was bagged.Patient and family updated through entire process." "yes, patient required additional needle procedure for iv placement" "causing fever and vomiting.".
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Search Alerts/Recalls
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