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

Catalog Number	530193
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2023
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 by the user facility: event 3: brief inquiry description: breaking fx catheters in patients.Detailed inquiry description: hospital reports 3 separate incidents of fx catheters breaking in patients backs.
Additional Manufacturer Narrative
Event 3: this report has been identified as b.Braun medical internal report number (b)(4).One used sample was returned for evaluation.In addition, one photo was provided.A visual evaluation of the photo showed an unwound spring catheter inside of a patient.Visual evaluation of the sample showed a used catheter attached to an extension set, and the tip had been sheared off.Per the manufacturer's investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.The user will be referred to the ifu which states, precaution: advancing the catheter more than 5 cm past the needle tip may increase the likelihood of kinking or knotting.Consult standard textbooks for specific techniques." 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
• 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: 17999600
• Report Number: 2523676-2023-00626
• Device Sequence Number: 6753740
• Product Code: OFT
• UDI-Device Identifier: 04046955589364
• UDI-Public: (01)04046955589364
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: 530193
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/03/2023
• 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