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

Catalog Number	333868
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: "during the attempt to place preservative free morphine in patients intrathecal space the anesthesia team noted a piece of the needle missing.They did not feel any resistance while withdrawing the needle.The decision was made to have the foreign body removed surgically." this event happened in the pre-op area, and then the broken off piece was surgically removed in the operating room.The xray suggests there was some bend to the needle in situ in the patient's back.It is unclear if there was additional bend from the surgical excision.
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).One used needle broken into two pieces was provided for investigation.Upon evaluation of the unit, the needle was observed to be severely damaged and bent.Luer taper testing was performed to verify the glass, metal, or plastic part, meeting specification.No weakness or nonconformities were observed in the material used to produce the needle.The reported issue was not confirmed to be the result of any manufacturing process.A 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.The spinal needle and introducer from the retain sample for the reported kit lot were visually evaluated per specification.Since the needle was not broken or damaged upon the opening of the kit and it had been used in a procedure, per the manufacturers investigation this defect is not likely to have happened during the manufacturing process.It is believed to happen during application.User should refer to ifu packaging notes stating: introducer needle may only be used for initial puncture and spinal needle introduction.Perform spinal puncture with the pencan needle and remove needle stylet.Warnings: · do not apply excessive force during needle advancement.Do not utilize needle if it bends or tip becomes damaged.Needle with damaged tip increases risk of post dural puncture headache due to extended perforation of the dura mater.· if blood in the csf continues to be seen after removal of stylet, withdraw the needle and retry at a different intervertebral space.· if no csf is observed, rotate the needle to all four quadrants and carefully aspirate until csf is visible.If this procedure does not show any flow of csf, repeat the spinal / lumbar puncture.· if paresthesia occurs after reaching the subarachnoid space, the needle should be slightly withdrawn.· if paresthesia occurs during injection, the needle should be repositioned prior to continuing the injection.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: SPINAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23295735
• Report Number: 2521402-2025-01170
• Device Sequence Number: 14674924
• Product Code: OFU
• UDI-Device Identifier: 04046964180866
• UDI-Public: (01)04046964180866(11)250715(17)270831(10)0062017306
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 Catalogue Number: 333868
• Device Lot Number: 0062017306
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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 Sex: Unknown