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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; EPIDURAL ANESTHESIA KIT
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B. BRAUN MEDICAL INC. PERIFIX®; EPIDURAL ANESTHESIA KIT Back to Search Results
Catalog Number 332081
Medical Device Problem Code Break (1069)
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).No sample and/or lot number was available for further evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed.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.
 
Event or Problem Description
As reported by the user facility: reported problem: end user stated that there was a laboring patient who had an epidural catheter in place without complication.During delivery the catheter snapped off at the yellow catheter hub.The catheter remained in patient and was then removed with tip intact.No injury reported.
 
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Brand Name
PERIFIX®
Common Device Name
EPIDURAL ANESTHESIA KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
MDR Report Key9438899
Report Number2523676-2019-00226
Device Sequence Number11668394
Product Code OGE
UDI-Device Identifier04046964177262
UDI-Public04046964177262
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
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
Report Date (Section B) 12/09/2019
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 Number332081
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2019
Initial Report FDA Received Date12/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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