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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY CATHETER,INTRAVASCULAR,THE

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B. BRAUN MELSUNGEN AG INTROCAN SAFETY CATHETER,INTRAVASCULAR,THE Back to Search Results
Catalog Number 4253566-03
Device Problem Protective Measures Problem (3015)
Patient Problem Needle Stick/Puncture (2462)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device history record (dhr): reviewed the device history record for batch number 19d14g8261 and there were no defect encountered during in process and final control inspection. Summary of root cause analysis: one used cannula of introcan safety-w pur 20g, 1. 1x32mm-ap without packaging was received. Protective cap and catheter hub were not returned for evaluation. During visual inspection, no any dent mark or abnormality has been observed from the cannula surface of all cannula orientation and observed that the safety clip was dislodged. Review of device history record for complaint batch shows no abnormality. Final control visual inspection and safety clip functional test results for complaint batch were reported as passed. Safety clip dislodged is able to be simulated during cannula withdrawal in extreme angle and with faster speed. The simulation results are consistent with the complaint defect. According to ifu, during application user should remove the cannula by pulling cannula straight back with a controlled, continuous motion parallel to the skin and the cannula is advisable to be disposed of immediately into the sharps container. Therefore, root cause could not be determined. Clip dislodged most likely not appear to be attributed by the manufacturing process as our assembly machines are equipped with 100% inspection by the vision systems for the clip on all parts is available at assembly machine, it is unlikely that the defect escape from process. Along the whole manufacturing process, there are no interference/ contact between clip hole and cannula crimping area. Safety clip dislodged is able to be simulated by withdrawing the cannula in certain angle which is not following ifu. 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 ((b)(4): the safety clip did not wrap the needle, which resulted in a needlestick for the nurse.
 
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Brand NameINTROCAN SAFETY
Type of DeviceCATHETER,INTRAVASCULAR,THE
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,
GM
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key11170441
MDR Text Key226837706
Report Number9610825-2020-00367
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
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 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4253566-03
Device Lot Number19D14G8261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/14/2021 Patient Sequence Number: 1
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