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

Model Number	333196
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: the patient gave informed consent for combined spinal epidural (cse) anesthesia and was brought to an operating room.The patient assumed a sitting position, and an anesthesiology resident, who was approximately halfway through their ca1 year (resident in first year of clinical anesthesiology training), performed local infiltration with approximately 3 ml of lidocaine 1% at the midline of the l5/s1 interspace using a 27-gauge needle that was 3.2 cm in length attached to a 3-ml luer lock syringe.The cse kit used was an eposcan combined spinal and epidural anesthesia tray manufactured by b.Braun medical.A cse technique was then attempted at this interspace, and insertion of the 12.7-cm pencan 25-gauge spinal needle through the tuohy needle did not produce backflow of cerebrospinal fluid.Rather than administer anesthesia in the epidural space, the plan was to reattempt a cse at a different lumbar interspace.The anesthesiology resident provided local infiltration at the l4/l5 interspace with an additional 3 ml of lidocaine 1% with the same 27-gauge needle.In conducting this local anesthetic infiltration, the resident inserted the needle superior to the interspace, partially withdrew the needle, and then inserted the needle inferior to the interspace.After complete withdrawal of the needle, it was noted that the needle had fractured from its hub and that a needle fragment was presumably retained in the subcutaneous tissue.The patient and attending obstetrician were immediately informed of this complication, but the patient denied any pain from the needle fragment at this time.The attending obstetrician spent approximately 10 minutes exploring the subcutaneous tissue with a scalpel and forceps attempting to remove the needle fragment while a general surgeon was consulted via telephone and advised that the patient could safely assume the supine position and that retrieval of the needle fragment could be deferred until after completion of the cesarean delivery.The attending anesthesiologist then successfully performed a cse anesthetic at the l5/s1 interspace, the patient was laid supine, and the cesarean delivery was performed without further incident.The patient was brought to the interventional radiology suite to attempt removal of the needle fragment.The patient was positioned prone and moderate sedation was achieved with intravenous fentanyl 150 [?]g and midazolam 8 mg given in divided doses.The patient had received hydromorphone 4 mg in an oral tablet approximately 5 hours before the procedure for incisional pain as the intrathecal morphine had been administered >24 hours earlier.Using fluoroscopy, the needle was visualized at the l4/l5 interspace.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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: ESPOCAN®
• 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: 14427196
• Report Number: 2523676-2022-00193
• Device Sequence Number: 17749466
• Product Code: OFT
• UDI-Device Identifier: 04046964179303
• UDI-Public: (01)04046964179303
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 333196
• Device Catalogue Number: 333196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 123 KG