MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; EPIDURAL ANESTHESIA KIT

Model Number	332097
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Epidural catheter (perifix fx springwound epidural catheter 19 gauges closed tip) was used to enter epidural space on a laboring patient.Epidural space was entered through midline approach without trauma.Epidural cath was threaded through tuohy needle but resistance was felt at the 13-15cm mark.Attempted to readjust needle and tried to advance cath but met with resistance again.Decision was made to completely remove cath however there was resistance when attempted to remove and the cath appeared to stretch.Attempted to remove tuohy needle with cath together but once tuohy needle was out, 6cm of cath remained in skin.Multiple attempts made and in multiple different positions but unable to remove cath.The following day options provided to patient and patient requested to have the catheter pulled.During retraction of the cath a "piece broke off".General surgery consulted to perform small incision cut down with exploration of dermal and epidermal layer (per ct imaging impression) but was unable to locate the remaining catheter.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 15264685
• Report Number: 15264685
• Device Sequence Number: 5871294
• Product Code: OGE
• UDI-Device Identifier: 04046964177354
• UDI-Public: 04046964177354
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2022
• Report Date (Section F): 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 332097
• Device Catalogue Number: 332097
• Device Lot Number: 0061820523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White
• Date Report Sent to FDA: 08/17/2022