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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY
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B. BRAUN MELSUNGEN AG INTROCAN SAFETY Back to Search Results
Catalog Number 4251601-02
Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/21/2015
Event Type  malfunction  
Event Description
As reported by the user facility: "the nurse was starting a piv and used the introcan safety needle.The safety part did not protect the nurse.It is activated when the needle is removed from the catheter and this did not happen".Customer did not save sample.There was no injury.
 
Manufacturer Narrative
(b)(4).The device has not been received yet and the investigation is ongoing at this time.A follow up report will be provided when the inspection results become available.(b)(4).
 
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Brand Name
INTROCAN SAFETY
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str.1
melsungen D-34 212
GM  D-34212
Manufacturer Contact
ludwig schuetz
carl-braun-str.1
melsungen D-342-12
GM   D-34212
661712769
MDR Report Key4760004
MDR Text Key5951276
Report Number9610825-2015-00152
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/05/2015,04/22/2015
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
Device Operator Other
Device Expiration Date11/01/2019
Device Catalogue Number4251601-02
Device Lot Number14M10G8361
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2015
Distributor Facility Aware Date04/22/2015
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer05/05/2015
Initial Date Manufacturer Received 04/22/2015
Initial Date FDA Received05/06/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/10/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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