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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNSPECIFIED ANGIOCATH CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNSPECIFIED ANGIOCATH CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. There was no sample or photo available to bd for evaluation. Therefore, bd was unable to perform a thorough investigation to verify the reported issue. Since, an investigation could not be performed bd was unable to determine a possible root cause. The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified. A review of the device history record could not be performed as the lot number was unknown. We appreciate you taking the time to bring this observation to our attention. We regret any inconveniences this incident may have caused you and your facility. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends. (b)(4).
 
Event Description
It was reported that an unspecified angiocath catheter had a damaged hub during use. The following was reported by the initial reporter: "at 17:40 on (b)(6) no. 20 the arterial indwelling needle in the department of critical care medicine (extracardiac) was broken at the connection between the needle handle and the needle, causing arterial leakage. Adr# (b)(4)".
 
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Brand NameUNSPECIFIED ANGIOCATH CATHETER
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
8015296192
MDR Report Key11159850
MDR Text Key226535417
Report Number9610048-2021-00009
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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