MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; SPINAL EPIDURAL ANESTHESIA KIT

Catalog Number	530192
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As reported, catheter shear off of the wire and the wire itself become lodged in a patient's back.Patient is having a xray to be sure that everything is out of her back and results are pending at this time.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample and one photograph were provided for evaluation.Upon visual inspection of the returned sample and photograph, it was observed that a single, used, sheared catheter with the coil stretched out and was exposed.Evaluation of the photo and sample did not confirm the reported defect of catheter occlusion.Based on the data from the investigation, the reported defect of catheter breakage was believed to happen during application.The pitch of the coil in the tip of the catheter has been determined to provide a correlation to kinking and occlusion during the use of the catheter.The pitch of the retain sample was measured per the drawing and found to be out of specification.An approved project is in place to further address issues with catheter breakage and occlusion.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: DESIGN OPTIONS®
• Common Device Name: SPINAL EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109
• MDR Report Key: 20467208
• Report Number: 2523676-2024-00929
• Device Sequence Number: 17955625
• Product Code: OFT
• UDI-Device Identifier: 04046955589340
• UDI-Public: (01)04046955589340(11)240506(17)250930(10)0061938751
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 530192
• Device Lot Number: 0061938751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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