• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN MELSUNGEN AG INTROCAN® SAFETY I.V. SAFETY CATHETER Back to Search Results
Model Number N/A
Device Problem Malposition of Device (2616)
Patient Problem Discomfort (2330)
Event Date 03/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). No samples were returned or any photos provided for this notification. Because of this, further evaluation and investigation on the complaint is not possible. Device history record review (dhr) : unable to review the device history record as this is an unknown batch number.
 
Event Description
As reported by the user facility ((b)(4)): snapped in patient arms.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
901 marcon blvd.
allentown 18109
4847197287
MDR Report Key6515350
MDR Text Key73515475
Report Number9610825-2017-00083
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K982805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/24/2017,04/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number4251128-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2017
Event Location Hospital
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-