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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN® SAFETY I.V. SAFETY CATHETER

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B. BRAUN MELSUNGEN AG INTROCAN® SAFETY I.V. SAFETY CATHETER Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No sample has been returned for investigation. Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event. A review of the batch and manufacturing records revealed no abnormalities or nonconformities.
 
Event Description
(b)(4): needle disappeared, then in users hand.
 
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Brand NameINTROCAN® SAFETY
Type of DeviceI.V. SAFETY CATHETER
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, hessen 34212
GM 34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown 18109
4842408332
MDR Report Key7074716
MDR Text Key93875827
Report Number9610825-2017-00236
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K982805
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
Report Date 12/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number4252594-01
Device Lot Number16N11G8241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2017
Distributor Facility Aware Date12/01/2017
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer12/01/2017
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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