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

Catalog Number	552116
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/01/2024
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 by user facility: registered nurse (rn) attempted to remove epidural catheter from patient's back while patient on her side and met significant resistance.Had patient curl around abdomen to open the spinal space.Still unable to remove epidural catheter.Rn called anesthesia provider to come evaluate.Anesthesia provider's attempt to remove epidural catheter and also met significant resistance.Due to patient not having much feeling in her legs anesthesia provider determined that more time should be given for sensation to come back to patient's legs.30 min later anesthesia provider returned to patient's bedside to reassess patient's sensation in legs.Sensation had improved and anesthesia provider attempted to remove epidural catheter while patient was sitting up hunched over abdomen.Anesthesia provider unable to remove epidural catheter.Has patient get onto hands and knees and was able to remove epidural catheter at this point, but the tip of the catheter did not come out.The catheter appeared to have uncoiled where it broke off and anesthesia provider attempted to remove the rest of the catheter but was unsuccessful.Anesthesia provider determined that patient was stable to move to postpartum and to pass along to the postpartum nurse to watch for signs of infection and that he would continue to follow up with the patient on postpartum.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample and eighteen unopened samples were provided for evaluation.Upon visual inspection of the returned sample, the used catheter showed it to be sheared and knotted.All unused catheters were removed from the kits and visually inspected.No damage, breakage or defects were observed on any catheter.Based on the data from the investigation, the reported defect was unable to be confirmed.Per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.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: 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: 20567771
• Report Number: 2523676-2024-00958
• Device Sequence Number: 7816349
• Product Code: OGE
• UDI-Device Identifier: 04046964950254
• UDI-Public: (01)04046964950254(11)240528(17)250930(10)0061938651
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: 552116
• Device Lot Number: 0061938651
• 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: 10/30/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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 Age: 32 YR
• Patient Sex: Female