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

Catalog Number	333868
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported by the user facility: per call with customer, a syringe in the kit had a piece of cardboard in it.The syringe could not be used.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One unused, single plastic syringe taped to packaging was returned for evaluation.In addition, one photo was also provided for evaluation.Visual evaluation of the returned sample and photo did not confirm any piece of cardboard inside of the syringe.The sample and photo were also evaluated by members of the kits mrb team and no particulates of any kind were able to be observed.Visual evaluation of the photo and returned product could not confirm the reported defect.However, it is possible the loose particulate could have fallen out of the syringe during transportation.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: 18587133
• Report Number: 2523676-2024-00053
• Device Sequence Number: 15238696
• Product Code: OFU
• UDI-Device Identifier: 04046964180866
• UDI-Public: (01)04046964180866
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/27/2024

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 333868
• Device Lot Number: 0061890154
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• 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
• Patient Sex: Unknown