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

Catalog Number	333512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: per health canada: patient requested epidural.During insertion resistance was felt by anesthesia and the tubing was pulled out.It was noted when catheter was removed the tip was not visible and the tubing appeared to be sheared and the metal guide wire had been pulled out of the tubing.Ct revealed tip is in area of l4.Extent of injury: a.Temporary not requiring medical intervention.B.Moderate to serious - temporary injury requiring medical intervention - as of nov 1/23 - patient remained asymptomatic but remains involved with medical team to determine long-term plan (leave in-situ vs.Surgically remove) - metal component of the tip has complicated this.C.Severe to critical - permanent injury that is not reversible d.Life threatening - life threatening injury or death has or could occur medical intervention performed: a.No intervention b.Nature of intervention · ct scan to confirm tip and location (sept 27) - 3.5 cm piece within the epidural space (from upper l3 to l3-l4 level).· consultation with spine-surgeon on call (sept 27) - recommended leave in situ.· interventional radiology fellow contacted (sept 28)- not able to successfully remove and recommended interventional neuroradiology consult.· interventional neuroradiology consulted (sept 29) - recommended leave in situ, patient wished referral with spine surgeon.· radiology re-read ct scan (oct 2) - presence of metallic component confirmed.· spine surgeon consulted (oct 17) -patient seen, discussed risks of surgical intervention, wished to determine catheter utilized and it's overall mri compatibility and discussion at spine rounds for approach to take · spine surgeon follow-up (nov 8) - notes in epic pending.What type of therapy was the patient receiving? epidural block during labour was therapy interrupted? no.Second catheter had been successfully placed and medications administered, broken tip for first catheter was noted when clean up after procedure occurred.Delivery was not impacted.The patient's care plan was adjusted to ensure she did not receive a bolus dose, as at the time they were unsure of the tip's placement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(6)).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18271184
• Report Number: 2523676-2023-00788
• Device Sequence Number: 19806758
• Product Code: OGE
• UDI-Device Identifier: 04046963899202
• UDI-Public: (01)04046963899202
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 333512
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female