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	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to b.Braun medical inc.That a pencan® (material 333851, lot 0061946960) was being used to administer anethesia on (b)(6) 2024.According to the complainant, spinal needle broke off in laboring patients back during the spinal procedure.Certified registered nurse anesthetist (crna) at bedside placing spinal for scheduled repeat caesarean section (c/s).After successful placement of local anethesia spinal needle was removed and found to have a missing tip.Mass drug administration (mda) notified to come to operating room (or).When c/s was completed crna alerted patient and obstetrics (ob) provider and xray was ordered stat.Confirmed needle tip was in patient's back.The complaint device has not been returned to the manufacturer for evaluation.
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).Three samples were provided for evaluation.Upon visual inspection of the returned samplea, one sample showed to be broken off from the tip, the two remaining unused needles were examined and no damaged or defects were able to be observed.Based on the data from the investigation, the reported defect was unable to be confirmed to be the result of any manufacturing defect.According to the manufacturer, the most probable root cause is the reported concern likely happened during application.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.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 (Section G): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109
• MDR Report Key: 20924571
• Report Number: 2523676-2024-01099
• Device Sequence Number: 12044477
• Product Code: OFU
• UDI-Device Identifier: 04046964180606
• UDI-Public: (01)04046964180606(11)240701(17)260531(10)0061946960
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 333851
• Device Lot Number: 0061946960
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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