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

Catalog Number	332200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: it was reported that 22cm of the 20g catheter sheared off in a patient while pulling back through the18g needle.Patient was seen in for caudally threaded epidural infusion up to l5/s1 level.Sacral hiatus was identified under fluoroscopy.Area was prepped and draped in routine manner.Skin and subcutaneous tissue were infiltrated with 4 ml of 1% lidocaine.Using a 17 gauge 3.5 inch touhy needle the caudal epidural space was confirmed under fluoroscopy.The epidural catheter was threaded through touhy needle and 2ml of contrast spread was visualized at l5/s1 level.After negative aspiration a total of 10ml of 0.5% lidocaine with 80mg of depomedrol was injected without resistance.There was no evidence of spinal anesthesia or intravascular injection.Upon removal of catheter it was noticed that tip was not intact.There was no resistance during catheter removal.Patient had no increased pain, numbness or ble weakness.No loss of bowel/bladder function.Orthopedics spine was consulted regarding possible intervention regarding retained catheter which is about 20cm.Patient and his wife were spoken to after procedure and informed of retained catheter.At that time patient again denied any new pain, weakness, or numbness.It was decided that patient see his spine surgeon immediately after.Surgical intervention was required to extract the catheter.Catheter was removed during surgery.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used catheter without packaging was returned for evaluation.Visual examination noted breakage of the catheter.Based on the results of the sample evaluation, our manufacturer determined they exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.Therefore, we can attribute this issue to a problem during application.Per the ifu, it states "never pull the catheter through the needle as it may otherwise shear off." review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7421734
• Report Number: 2523676-2018-00025
• Device Sequence Number: 13649461
• Product Code: OGE
• UDI-Device Identifier: 04046964178061
• UDI-Public: 04046964178061
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 332200
• Device Lot Number: 0061379553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR