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

Catalog Number	332220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although it was confirmed that the device involved is not available for evaluation, 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: the patient was reporting increased pain, when the nurse went to assess the catheter it was discovered the catheter was disconnected from the clamp.Epidural became disconnected between the thin epidural catheter and clamp that connects to the epidural tubing.The catheter came out of the connector but not the patient.The nurse bloused the patient's epidural in attempts to get her comfortable again.The catheter continued to be used.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400434464.No sample was returned for further evaluation.Retain samples were pulled and tested.All testing were within specification.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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: 8726276
• Report Number: 2523676-2019-00095
• Device Sequence Number: 11268085
• Product Code: OGE
• UDI-Device Identifier: 04046964178320
• UDI-Public: 04046964178320
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 332220
• Device Lot Number: 0061661811
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR