MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ESPOCAN®; SPINAL EPIDURAL ANESTHESIA

Catalog Number	333196
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 involved is not available for evaluation, the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.It should be noted that the following lot number was provided; however, the lot number mentioned below is not one that was used.Lot number: 0061650943.Production date: 12/11/2018.Expiry date: 08/31/2020.
Event or Problem Description
As reported by the user facility: event 3: customer reports, "we have had about 7 instances where the catheter connector comes off of the epidural." no injury reported.
Additional Manufacturer Narrative
Event 3: this report has been identified as b.Braun medical internal report number (b)(4).No sample was returned for further evaluation.For continued safe use of the perifix catheter connector a detailed step-by-step instructions of how to use the perifix catheter connector label and cloth/silk medical tape has been provided.Review of the discrepancy management system (dsms) database was performed for the reported lot numbers 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: ESPOCAN®
• Common Device Name: SPINAL EPIDURAL ANESTHESIA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9075108
• Report Number: 2523676-2019-00159
• Device Sequence Number: 2976798
• Product Code: OFT
• UDI-Device Identifier: 04046964179303
• UDI-Public: 04046964179303
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/31/2019

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 Catalogue Number: 333196
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1