MAUDE Adverse Event Report: PENCAN®; SPINAL ANESTHESIA KIT

Model Number	333868
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 conversation, the facility is reporting an incident about 10 days ago where a (b)(6) y.O.Male was undergoing a procedure with our product ref (b)(4) lot 0061785913 when the 24g x 4 in pencan spinal needle broke off and the tip was retained by the patient.The patient required transfer to a different facility for possible removal.There is no additional information available at this time.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used spinal needle and inner tray with packaging was provided for evaluation.Visual evaluation of the used needle showed the very end of the needle tip to be broken off.Although the tip of the needle was broken off, since it was not broken or damaged upon the opening of the kit and it had been used in a procedure, it is not confirmed to be a manufacturing defect.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." 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
• MDR Report Key: 12490751
• Report Number: 2523676-2021-00313
• Device Sequence Number: 18469800
• Product Code: OFU
• UDI-Device Identifier: 04046964180866
• UDI-Public: (01)04046964180866
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 01/31/2023
• Device Model Number: 333868
• Device Catalogue Number: 333868
• Device Lot Number: 0061785913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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 Age: 67 YR