MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT

Model Number	552116
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
(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As per user facility, event 4: facility reported catheter connectors are declasping.About 4 trays have been affected.No patient injury.
Additional Manufacturer Narrative
Event 4: this report has been identified as b.Braun medical internal report number (b)(4).One (1) used kit was returned for evaluation.Visual examination of the contents of the kit notes that the sample did not contain the reported component.No catheter connector inside the kit to evaluate.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.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: DESIGN OPTIONS®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8574593
• Report Number: 2523676-2019-00050
• Device Sequence Number: 11305932
• Product Code: OGE
• UDI-Device Identifier: 04046964950254
• UDI-Public: (01)04046964950254
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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 Expiration Date: 06/30/2020
• Device Model Number: 552116
• Device Catalogue Number: 552116
• Device Lot Number: 0061647945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1