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

Model Number	560603
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) single used needle with opened packaging was returned for evaluation.Visual evaluation did note the used needle to be broken off at the hub.Although visual evaluation noted the needle to be broken off the hub, since the kit had already been opened and used for a procedure, it is not confirmed to be the result of any manufacturing process.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.User will be referred to the ifu which states, " do not apply excessive force during needle advancement.Do not utilize needle if it bends or tip becomes damaged.If resistance is feltduring advancement of the needle, carefully correct the orientation of the needle but never apply excessive force.".Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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.
Event or Problem Description
As reported by the user facility: detailed inquiry description: we had a spinal needle break off from the hub in surgery while anesthesiologist was positioning the needle.Surgeon had to make incision and retrieve needle with forceps.Skin sutured.General anesthesia given.No spinal.

• Brand Name: DESIGN OPTIONS®
• Common Device Name: SPINAL 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: 16864591
• Report Number: 2523676-2023-00131
• Device Sequence Number: 14798951
• Product Code: OFU
• UDI-Device Identifier: 04046964320842
• UDI-Public: (01)04046964320842
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 560603
• Device Catalogue Number: 560603
• Device Lot Number: 0061870101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 108 KG