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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 4251601-020
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/26/2021
Event Type  Injury  
Manufacturer Narrative
This report has been identified as b. Braun internal report number (b)(4). The complaint is still under investigation. A follow-up report will be provided, as soon as investigation has been completed. 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): "broken device" "customer report serious adverse event with catheter periferic. Patient with very difficult venous access, in his 11th day of hospital stay, who today on (b)(6) 2021 in the early hours of the morning (00: 03) manifested no permeability of the peripheral venous catheter, so auxiliary nurse on duty performs removal of this and change, after aseptic technique with chlorhexidine + saline solution 0. 9% performs venipuncture in one attempt, in the proximal third of the right forearm, the access was checked for patency, and the patient manifested pain at the venipuncture site during the morning shift of the same day on (b)(6) 2021, so the assistant on duty, after the first attempt, placed a heparinized plug and fixed it with micropore without any complication, so auxiliary on duty after aseptic technique performs removal of this, showing that catheter remains in the intravenous line, removing only cone catheter connection plus heparinized catheter, pressure is applied, fixed with micropore, the general physician on duty is immediately informed, who in turn informs the vascular surgeon for assessment and removal of the catheter, the patient's safety is notified, the patient is hemodynamically stable, no venous access is left. ".
 
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Brand NameINTROCAN
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
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key12488065
MDR Text Key271913218
Report Number9610825-2021-00389
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeCO
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,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4251601-020
Device Catalogue Number4251318
Device Lot Number20M11G8301
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 Received08/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2020
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: 09/17/2021 Patient Sequence Number: 1
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