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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 Fracture (1260)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
(b)(4). No samples were returned, but picture of a capillary of an introcan safety-w pur 20g, 1. 1x32mm-ap has been provided. From the picture provided, the capillary was observed to be cut off. Further investigation will be done based on photo given. From the observation on the received picture the used capillary hub has shorter length of the capillary. The cut off part of capillary cannot be seen in the picture and the surface of the torn off area was not visible. Cut off capillary most likely not appear to be attributed by manufacturing process as the defect is able to be detected and reject by the in-line vision system. Damages induced after assembly process is not possible since the catheter had been protected with protective cap. Since no defect samples provided, no further investigation can be carried out thus this complaint will be concluded as not confirmed. This complaint will be filed for statistical purpose. Device history record review (dhr): reviewed the device history record for batch number 19b27g8271 and no abnormalities found during in process and final control inspection. 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)): product broken / capillary. The broken catheter was removed after the vascular surgery.
 
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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, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, pa 
2408332
MDR Report Key10092468
MDR Text Key192201457
Report Number9610825-2020-00110
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
Type of Report Initial
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4253566-03
Device Lot Number19B27G8271
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/27/2020 Patient Sequence Number: 1
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