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

Model Number	4512014C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: the doctor inserted the catheter and found that it was placed too deeply.Then doctor removed catheter from the patient, and it was found to be stretched and broken.
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.The following investigations were conducted: visual inspection: the received customer pictures were taken to a visual inspection for damages according to the test method 102002 damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G.The impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: the first customer picture shows an overstretched catheter where the catheter end is supposed to be torn off, which cannot be seen in the customer picture, and a comparison sample, see customer picture.The second customer picture shows the package with the variable data.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off." batch history review: perifix one paed set (b)(6).Ref.: 4512014cx.Lot.: 22a25a8701.Perifix one paed ã[?]0,59mm (24g) 50mm p.Ref.: 8445819.Lot.: 22a18a6561, 22a19a6561, 22a20a6561, 21l27a6561.Functional inspection: n.A.Physical inspection: n.A.Summary and assessment: we 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 assume a fault during the application process and we consider the complaint as not confirmed.Based on the conducted investigations the received sample is within the specification.Therefore, the complaint is considered as not confirmed.The investigation sample(s) is/are not available.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• 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: 21167787
• Report Number: 9610825-2024-01029
• Device Sequence Number: 19901846
• Product Code: OGE
• UDI-Device Identifier: 04046964941511
• UDI-Public: (01)04046964941511(11)220125(17)270101(10)22A25A8701
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 01/16/2025

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: 4512014C
• Device Lot Number: 22A25A8701
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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