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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 22GA X 1,00IN 0,9 X 25MM INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 22GA X 1,00IN 0,9 X 25MM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38833514
Device Problems Leak/Splash (1354); Product Quality Problem (1506); Positioning Problem (3009)
Patient Problems Extravasation (1842); Hematoma (1884)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the angiocath 22ga x 1,00in 0,9 x 25m did not have adequate lubrication and made the puncture difficult, facilitating the loss of venous access, causing leakage of blood and chemotherapeutic drugs into the patient's skin. The exposure was reportedly identified quickly, preventing further damage and major injury. The following information was provided by the initial reporter, translated from portuguese to english: peripheral intravenous catheter nº 22, the same does not have a good lubrication, making puncture difficult and facilitating that the technician loses the venous access. As the catheter do not slide correctly in the puncture, the customer lost the vein access and it was need to make new punctures. Because of that the patient had presents dilated vein and hematoma. Besides that, there was a leakage of blood and chemotherapy in the patient skin. This chemotherapy is vesicant and irritant, but there was no bigger damage because this leakage was fast identified. At the time of the loss of the vein, the patient was exposed to blood and chemotherapeutic drugs, vesicants and irritants. These medications just did not cause further damage because they were seen in time to cause any major injury.
 
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Brand NameANGIOCATH 22GA X 1,00IN 0,9 X 25MM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8653889
MDR Text Key146497369
Report Number9610048-2019-00195
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number38833514
Device Lot Number8270929
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 Received05/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2018
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: 05/30/2019 Patient Sequence Number: 1
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