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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 332216
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 08/09/2017
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 reported by the user facility: during placement of epidural catheter for female patient in labor and delivery, a 7cm portion broke off and was retained in patient.Second epidural placed successfully.No further treatment is anticipated; however, a neuro consult will be obtained.
 
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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 Key6871070
Report Number2523676-2016-00152
Device Sequence Number1071519
Product Code OGE
UDI-Device Identifier04046964178269
UDI-Public04046964178269
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 08/09/2017
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 Date09/30/2018
Device Catalogue Number332216
Device Lot Number0061562598
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/09/2017
Initial Report FDA Received Date09/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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