Design Options®

Description of Event or Problem

Situation: During skin infiltration with local anesthesia at the start of an epidural placement for labor analgesia the shaft of the 30 g needle separated from the needle hub and was not able to be retrieved from the subcutaneous tissue.Background: 30g (1 inch) skin infiltration needles are contained within epidural kits.Assessment: The patient underwent general surgery under general anesthesia in order for the needle shaft to be removed from the patient's back (subcutaneous tissue).Recommendation: BBraun have been notified about this incident and we are investigating using alternative needles for skin infiltration.S ¿ SituationDuring epidural placement for labor analgesia on "[redacted]", the local/infiltration needle fractured and became retained in the patient¿s lumbar subcutaneous tissue.B ¿ BackgroundThe patient was admitted for a term induction of labor and subsequently had a vaginal delivery. During the epidural procedure, the anesthesia team documented that the local/infiltration needle fractured and remained under the skin in the lumbar region. The location of the retained foreign body was marked with skin marker. The patient reported no pain at the site at the time of post-procedure assessment.Diagnostic imaging was ordered and obtained. General Surgery and Neuro Spine were consulted. Following review of imaging and specialty evaluation, General Surgery proceeded with removal of the retained foreign body in the OR. The anesthesia team notified Risk Management and contacted BBraun, the device manufacturer.A ¿ AssessmentThis was a retained foreign body/device-related safety event associated with epidural placement. The retained needle fragment required diagnostic imaging, specialty consultation, and operative removal.R ¿ RecommendationRecommend review of the event to identify contributing factors and any opportunities for process improvement. Notify the device manufacturer and appropriate regulatory bodies as required. Recommend proactive follow-up by Patient Experience with the patient and family to address any concerns following discharge.Product involved is only the 30g (1 inch) skin infiltration needle that was within this kit.