• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC YEL 24GA X 0.75IN INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOG BC YEL 24GA X 0.75IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382512
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
The initial reporter also notified the fda on (b)(6) 2020. Medwatch report # (b)(4). Report source other: medwatch report (b)(4). Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident. A device history record review showed no non-conformances associated with this issue during the production of this batch. Investigation conclusion: 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. Root cause description: the reported defect could not be refuted nor confirmed in the absence of a sample. The root cause cannot be determined for an unconfirmed defect. Rationale: customer complaint trends are evaluated on a monthly basis, however the need for a formal corrective action cannot be determined in the absence of the root cause.
 
Event Description
It was reported that insyte autog bc yel 24ga x 0. 75in needle was loose. The following information was provided by the initial reporter: material no. : 382512, batch no. : 9190483. It was reported that the device could not be inserted into patient's skin due to device being wiggly and loose.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINSYTE AUTOG BC YEL 24GA X 0.75IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11340428
MDR Text Key232283954
Report Number1710034-2021-00117
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382512
Device Lot Number9190483
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 Received01/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-