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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT
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DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT Back to Search Results
Model Number 552175
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/10/2021
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: end user reports, "catheter broke at the site of the connector when disconnected." two potential lots were provided: lot number 0061756354: expiry date 01/01/2022; production date 11/30/2020.Lot number 0061763917: expiry date 01/01/2022; production date 01/27/2021.No injury reported.
 
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Further investigation of the complaint is not possible.  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.
 
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Brand Name
DESIGN OPTIONS®
Common Device Name
EPIDURAL ANESTHESIA KIT
MDR Report Key12036948
Report Number2523676-2021-00188
Device Sequence Number19237986
Product Code OGE
UDI-Device Identifier04046955589463
UDI-Public04046955589463
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/23/2021
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 Model Number552175
Device Catalogue Number552175
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/15/2021
Supplement Date Received by Manufacturer06/15/2021
Initial Report FDA Received Date06/21/2021
Supplement Report FDA Received Date07/23/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
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 Number1
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