Catalog Number 382534 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle partially retracted and the needle was through the catheter while introducing the catheter.The following information was provided by the initial reporter: describe the event or problem: narrative from staff: successful placement of 20g piv to lfa (left femoral artery), unable to retract needle with button on handle of catheter.Unable to advance the catheter off the needle.It felt "stuck".
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Manufacturer Narrative
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Age or date of birth.Date of birth: patient¿s birthday was not provided, (b)(6) 1985 was used based on age of patient.Device evaluated by mfr.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The initial reporter also notified the fda on july, 2022.Medwatch report # 2000330000-2022-8036.
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Manufacturer Narrative
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H6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter needle partially retracted and the needle was through the catheter while introducing the catheter.The following information was provided by the initial reporter: describe the event or problem: narrative from staff: successful placement of 20g piv to lfa (left femoral artery), unable to retract needle with button on handle of catheter.Unable to advance the catheter off the needle.It felt "stuck".
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Search Alerts/Recalls
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