MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG PENCAN®; SPINAL ANESTHESIA KIT

Catalog Number	4502043-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the event descritpion: a patient with chronic and complex anal fistula for several years.The patient was operated on for proctological exploration.During puncture for spinal anesthesia, when the needle was withdrawn, the last two centimeters of the needle were found to be missing: the needle had broken off, with a clean cut approximately 2 centimeters (cm) from the tip.The missing end of the needle remained in the patient.Spinal anesthesia was discontinued and the patient switched to a much heavier general anesthesia, which entailed considerable risk for the patient.Following neurosurgical advice and a ct scan, the needle tip in the patient will not be removed unless complications arise.Increased infectious surveillance.Reportedly the broken part was recovered.The patient's bmi was 25.95 kg/m² at the time of surgery.Operative time was prolonged, and the patient had to be re-operated to remove the remaining part of the needle.The introducer was in place at the time of puncture.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.Additional information: d9 device returned to manufacturer expertise report we received for examination a pencan 25gx3 ½ needle used without blister and a new needle of the same reference in an open blister.The needles were subjected to visual inspection.On the incriminated needle, we observed a break in the cannula 25 mm from its distal end (see photos).The break area was analyzed and shows that the cannula was bent before breaking.No damage was noted on the new needle received.A dimensional check was performed.The outer diameter of the cannula was measured at several points.Nominal value: 0.53 mm ± 0.01 mm measured value on the incriminated device: 0.53 mm measured value on the new device: 0.53 mm the measurements are in accordance with product specifications.Conclusion the measured values conform to the specifications, and the break area shows deformation by bending before breaking during use.We assume there was an issue during the application process.We remind you that in case of difficulties that may be related to the patient's anatomy (e.G., high bmi), it is essential to avoid applying excessive force during insertion, as the spinal needle may bend or even break.Furthermore, contact with bone tissue may blunt or deform the needle tip.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: PENCAN®
• Common Device Name: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20789728
• Report Number: 9610825-2024-00855
• Device Sequence Number: 7895228
• Product Code: OFU
• UDI-Device Identifier: 04046964180804
• UDI-Public: (01)04046964180804(11)231130(17)281101(10)23M30H8B03
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 4502043-13
• Device Lot Number: 23M30H8B03
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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: Required Intervention
• Patient Sex: Unknown