Catalog Number 38831214 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
Pain (1994)
|
Event Date 10/19/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the tip of the bd insyte¿ iv catheter bent during the infusion.The following information was provided by the initial reporter, translated from portuguese: "peripheral catheter presents resistance when being removed from the skin causing pain to the patient, at the end of the procedure it was observed that the tip had bent.".
|
|
Manufacturer Narrative
|
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
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.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h10.
|
|
Event Description
|
It was reported that the tip of the bd insyte¿ iv catheter bent during the infusion.The following information was provided by the initial reporter, translated from portuguese: "peripheral catheter presents resistance when being removed from the skin causing pain to the patient, at the end of the procedure it was observed that the tip had bent.".
|
|
Search Alerts/Recalls
|