MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG PERIFIX®; EPIDURAL ANESTHESIA

Catalog Number	8713050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.After checking the respective documentation of the production (shift record, results of worker self-inspection and in-process control, machine documentation, cleaning record etc.) no deviations could be identified in the mentioned time period.The following investigations were conducted: visual inspection: no sample was received and thus a further evaluation and investigation of the complaint is not possible.Summary and assessment: as no sample and no picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample will be provided, the complaint will be re-opened accordingly.
Event or Problem Description
According to the event description: during the procedure (epidural anesthesia) the catheter broke.Clinical, neuroimaging and neurosciences follow-up were performed, without finding neurological alterations or tomographic evidence of catheter residues.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20644995
• Report Number: 9610825-2024-00818
• Device Sequence Number: 7404057
• Product Code: OGE
• UDI-Device Identifier: 04046964558641
• UDI-Public: (01)04046964558641(17)290201(10)24B15A8701
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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 Catalogue Number: 8713050
• Device Lot Number: 24B15A8701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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
• Patient Sex: Unknown