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

Model Number	332216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Initial mdr is being submitted retrospectively due to a filing error by b.Braun medical inc.At the time of the reporting.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: during placement of epidural catheter for female patient in labor and delivery, a 7cm portion broke off and was retained in patient.Second epidural placed successfully.No further treatment is anticipated; however, a neuro consult will be obtained.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, pa ; 7197287
• MDR Report Key: 6980851
• Report Number: 2523676-2017-00152
• Device Sequence Number: 19441231
• Product Code: OGE
• UDI-Device Identifier: 04046964178269
• UDI-Public: 04046964178269
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 09/30/2018
• Device Model Number: 332216
• Device Catalogue Number: 332216
• Device Lot Number: 0061562598
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 10/26/2017
• Date Device Manufactured: 05/30/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown