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

Catalog Number	551630
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has 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 reported by the user facility: issue: anesthesiologist pulled up lidocaine w/epinephrine using the syringe and filter straw in the tray.Multiple white, particulate found floating in solution.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) 20ml syringe and four (4) pictures were returned in connection with this complaint.Visual examination of the returned syringe noted the syringe to have white particulates floating in the fluid.The pictures depicted the same defect.The syringe and all available information has been forwarded to the manufacturer for further investigation.Per the manufacturer's investigation, the reported defect was confirmed.The sample was visually inspected and a yellowish contamination was observed inside the syringe cylinder.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.Based on the manufacturer's evaluation results, incidents of this nature can be attributed to the injection molding process.Set material in the molding tool or machine is the cause of this inclusion.This could be due to a large shear force occurring in the machine or tool, after a production break.To minimize the occurrence of this defect, the products from the first cycles are scrapped after every longer production stop.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• 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: 8133449
• Report Number: 2523676-2018-00099
• Device Sequence Number: 1693062
• Product Code: OGE
• UDI-Device Identifier: 04046964307560
• UDI-Public: 04046964307560
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 12/27/2018

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: 11/30/2019
• Device Catalogue Number: 551630
• Device Lot Number: 0061629552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1