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

Catalog Number	333851
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: on (b)(6) 2022, doctor attempted to administer the spinal block in patient's lower back twice.Doctor used a 25 g 3.5 cm pencil-tip needle on the first attempt.On the second attempt, doctor utilized a 25g 4-inch pencan by b.Braun medical inc.When administering the second spinal block, the spinal needle tip broke in patient's lower lumbar spine.Doctor proceeded with administering the epidural after found that the "spinal needle appeared shorter than when initially placed" and the needle "appeared altered upon removal of the spinal needle." doctor continued the procedure by administering the epidural with a 17g tuohy needle while the tip of the spinal needle remained embedded in the patient's lumbar spine.After delivery, patient was transferred to pacu to be evaluated for removal of the "spinal catheter tip." patient underwent an x-ray and ct of lumbar spine.The assessment of patient's spine showed that there is a 2.4 cm needle fragment superficial to the right lamina of l3.The needle tip is located at lamina and extends along the posterior spinous process.It does not enter the spinal canal.There are bubbles in the paraspinous area at l4.There are also air bubbles in the epidural region throughout the lumbar spine.Patient was prescribed and administered ibuprofen, acetaminophen, and oxycodone as postoperative pain medications to control breakthrough pain.However, patient experienced and complained of low back pain following operation.Patient requested the removal of the spinal needle prior to discharge.However, "no urgent surgical intervention indicated" was documented in patient's medical chart.Around (b)(6) 2022, patient was visited by doctors to discuss the ct scan of lumbar spine.Doctors advised patient that removal was an option they did not recommend at that time.Patient was discharged from hospital with the spinal needle remaining in lumbar spine.At a medical visit on (b)(6) 2023, doctor reported impressions of "metallic fragment at the right lateral aspect of the spinous process at l3" and "mild degenerative changes of the lumbar spine with mild to moderate narrowing of the exit foramina" in patient.Patient saw another doctor on (b)(6) 2023 and reported experiencing chronic pain in lower back.The doctor after acknowledging previous doctor's impressions, disregarded patient's complaints.There was no medical intervention at that visit.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Section d1 has been updated to pencan®, catalog 333851, and udi (b)(4).Thirty- four additional retain lots were visually inspected and passed.No sample or lot number was provided for evaluation.The reported defect was unable to be confirmed.The exact root cause is unable to be determined.The manufacturer states it likely happened 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: PENCAN®
• Common Device Name: EPIDURAL 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: 18363765
• Report Number: 2523676-2023-00852
• Device Sequence Number: 8109032
• Product Code: OGE
• UDI-Device Identifier: 04046964180606
• UDI-Public: (01)04046964180606
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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 Catalogue Number: 333851
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown