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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD INSYTE¿ AUTOGUARD¿ CATETER I.V. 24G X 0.75¿ (0.7 X 19 MM) INTRAVASCULAR CATHETER

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BECTON DICKINSON IND. CIRURGICAS LTDA BD INSYTE¿ AUTOGUARD¿ CATETER I.V. 24G X 0.75¿ (0.7 X 19 MM) INTRAVASCULAR CATHETER Back to Search Results
Model Number 381812
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident. Examination of the product involved may provide clarification as to the cause for the reported failure. A device history record review showed no non-conformances associated with this issue during the production of this batch. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that bd insyte¿ autoguard¿ cateter i. V. 24g x 0. 75¿ (0. 7 x 19 mm) had the needle through the shield. The following information was provided by the initial reporter: "insyte with package perforated by the device's own needle. ".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ CATETER I.V. 24G X 0.75¿ (0.7 X 19 MM)
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key12733953
MDR Text Key279958294
Report Number3003916417-2021-00333
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818129
UDI-Public00382903818129
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381812
Device Catalogue Number38181214
Device Lot Number0190155
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2020
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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