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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG INTROCAN I.V. SAFETY CATHETER Back to Search Results
Model Number N/A
Device Problem Protective Measures Problem (3015)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun melsungen ag internal report (b)(4). We received: 4 used cannula out of an introcan safety pur 14g, 2. 2x50mm-eu in open packaging. The returned samples were subjected to a visual examination (position of the clip) according to the test plan. Nominal: (test only safety version): both arms of the safety clip must be sitting in the groove of the housing. Actual: the clips of two sample are not sitting in correct position. A function inspection was not possible, because only the cannula and not the cannula housing has been returned. We have informed our manufacturing department accordingly. The complained samples were forwarded to our manufacturing department for further evaluation. A follow-up report will be provided after the statement is available. Device history record review (dhr): reviewed the dhr and no abnormalities found during in process and final control inspection. Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b. Braun medical, inc.
 
Event Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): safety system-dysfunction-prick. Use of catheters, intra-abdominal transcutaneous puncture at laparoscopy. 4 catheters of the same batch used, one of them malfunctioned: the automatic protection did not cover the tip of the needle, and the surgeon was injured on the finger causing a declared.
 
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Brand NameINTROCAN
Type of DeviceI.V. SAFETY 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 Key9251415
MDR Text Key197938653
Report Number9610825-2019-00512
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 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number4251717-01
Device Lot Number18H09G8241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2018
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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