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

Catalog Number	333851
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: detailed inquiry description: spinal attempted for anesthesia.1st attempt by srna unsuccessful, introducer & spinal needle removed as one unit.2nd attempt by crna.Redirection of spinal needle did not yield csf.Intro & needle removed to attempt redirection.Introducer intact.Spinal not intact upon removal.No resistance met upon removal.Md notified for further assistance.Ultrasound guidance did not yield visualization of needle tip.No injury reported.
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).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.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.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.
Event or Problem Description
Additional information provided: patient ended up receiving a ct and surgery was done to remove the needle.Patient is fine.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two partially used trays and one broken needle with opened packaging were returned for evaluation.Visual evaluation showed used contaminated components in the trays.Visual observation of the used needle showed it the be severely bent, damaged, and sheared into three pieces.Although several sheared pieces were returned since the product had been opened and used in a procedure, it is not confirmed to be the result of any manufacturing process.Although needle was broken off into three pieces, since it 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 will be referred to the ifu which states, " do not apply excessive force during needle advancement.Do not utilize needle if it bends or tip becomes damaged.If resistance is feltduring advancement of the needle, carefully correct the orientation of the needle but never apply excessive force.· 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" 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.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.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17790998
• Report Number: 2523676-2023-00570
• Device Sequence Number: 12375567
• Product Code: OFU
• UDI-Device Identifier: 04046964180606
• UDI-Public: (01)04046964180606
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/31/2023

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 333851
• Device Lot Number: 0061882432
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 09/08/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/04/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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 Age: 24 YR
• Patient Sex: Female