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

Model Number	4514017C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description: on (b)(6) 2024 at 5pm there was an attempt to perform an epidural insertion.The first attempt by intern fails.There was a successful insertion on second attempt by senior anesthetist.Reportedly the epidural does not work.At 7pm a second epidural was inserted after removal of first epidural catheter; a piece of kt (approximately 7 to 8 centimeters) is missing.Checked by ct scan the next day: the kt is in the patient's back.Patient informed - no particular pain but psychological shock.Decision to leave the kt in place.An ultrasound project is planned in 1 month to verify the appearance of a granuloma.
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 one perifix one 401 filterset in open packaging.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: at the used perifix one ø0,84mm (20g) 80mm p the part with the catheter tip is cut off.The cut off area shows a smooth structure (see picture).The cut off part was not handed over by the customer.The surface of the cut leads to the assumption that this damage was caused by a sharp object during the application process.The damaged area at the catheter is slanted and is due to the retraction of the catheter in the cannula.Note: such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off."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 outside diameter and the length of the perifix one ø0 ,84mm (20g) 80mm p were measured according drawing.Outside diameter: nominal: 0.84 mm +-0.04 mm actual: between 0.82 mm and 0.83 mm.Length of the catheter: nominal: 1010 mm +- 7.5 mm actual: approx.950 mm 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 and therefore, we consider the complaint as not confirmed.Based on the conducted investigations the checked sample is within the specification.Therefore, the complaint is considered as not confirmed.

• 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: 21167786
• Report Number: 9610825-2024-01024
• Device Sequence Number: 4273098
• Product Code: OGE
• UDI-Device Identifier: 04046964558795
• UDI-Public: (01)04046964558795(11)240820(17)290801(10)24H20A8701
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• 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: 4514017C
• Device Lot Number: 24H20A8701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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