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

Catalog Number	333858
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although it was confirmed that the device is not available for further evaluation, 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: problem: end user states that during a procedure the patient (male) received an uneventful/uncomplicated spinal and during insertion the needle broke off.An attempt was made to excise the broken piece without success.Patient was scanned and it was confirmed the patient had retained the piece in soft tissue.The patient did not have any affects.Patient was referred to neurosurgeon for follow up customer to confirm if the patient had surgery delayed or not.It was confirm that the patients procedure was aborted due to the defect.The patient was asymptomatic; however was referred to neurosurgery.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A sample was confirmed not to be available.Without the actual device, a thorough investigation could not be performed.While we are unable to confirm the specific nature of the reported event, 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 a sample and/or 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
• MDR Report Key: 7791876
• Report Number: 2523676-2018-00063
• Device Sequence Number: 19154352
• Product Code: OFU
• UDI-Device Identifier: 04046964180705
• UDI-Public: 04046964180705
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/26/2018

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: 11/30/2020
• Device Catalogue Number: 333858
• Device Lot Number: 0061607899
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention