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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX SOFT TIP EPIDURAL CATHETER

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B. BRAUN MELSUNGEN AG PERIFIX SOFT TIP EPIDURAL CATHETER Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 05/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). We received no sample and no picture. The defect is due to a development error and already known. Therefore this complaint is consider as confirmed. A review of the batch and manufacturing records revealed no abnormalities or nonconformities. The complaint is filed for statistical purpose.
 
Event Description
As reported by the user facility ((b)(4)): connector/catheter-detached.
 
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Brand NamePERIFIX SOFT TIP
Type of DeviceEPIDURAL CATHETER
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon boulevard
allentown, PA 18109
4842408332
MDR Report Key8712484
MDR Text Key148444741
Report Number9610825-2019-00225
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number4512006C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2019
Device Age9 MO
Event Location Hospital
Date Report to Manufacturer07/02/2019
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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