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

Catalog Number	4514017C
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.We received one used perifix one ø0,84mm (20g) 80mm p out of a perifix one 401 filter set without packaging and 3 x-ray from the customer.Because we received no batch information from the customer, an examination is not possible if there were any abnormalities in the manufacturing process or in the check routine of the final control.The following investigations were conducted: visual inspection: the received catheter out of the set was 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 used perifix one ø0,84mm (20g) 80mm p is torn / sheared off.The torn off part with the catheter tip was not handed over by the customer.The catheter end was also cut off and not handover by the customer.The received catheter part is approx.310 mm long (should be 1010 mm +- 7.5 mm completely, pm: 1806).The shorn off area at the catheter tip is slanted.The separated area is slanted, and the structure is due to the retraction of the catheter in the cannula.Note: such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off." functional inspection: n.A.Physical inspection: in addition, the outer diameter of the perifix catheter was measured according to the drawing.The measured value of the catheter is within the specifications.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.Because of this we assume of a problem during the application process.Based on the conducted investigations the tested sample is within the specification.Therefore, the complaint is considered as not confirmed.
Event or Problem Description
According to the complainant an epidural catheter placement was performed on the night on (b)(6) 2024.The placement was without an issue.One puncture, catheter insertion without difficulty, effective epidural analgesia.Reportedly the catheter was removed without difficulty or traction.Upon removal the device was missing 5 millimeters (mm) at the end of the catheter.An ultrasound and ct scan were performed and nothing was visible.The fragment remained in the patient's epidural space.

• 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: 20926654
• Report Number: 9610825-2024-00906
• Device Sequence Number: 5105792
• Product Code: OGE
• UDI-Device Identifier: 04046964941450
• UDI-Public: (01)04046964941450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/13/2024

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: 4514017C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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