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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IAG BC PRO GLOBAL PNK 20GA X 1.0IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IAG BC PRO GLOBAL PNK 20GA X 1.0IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381033
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that iag bc pro global pnk 20ga x 1. 0in was not able to connect. The following information was provided by the initial reporter: on the (b)(6) 2021, in the hospital carried out a material vigilance on the 20g catheter. "catheter set up for an injected scan. When connecting the catheter to the infusion tubing, impossible to connect the catheter to the tubing. After testing, no problem with the tubing, it is the luer tip of the catheter that causes the problem. Need to change the catheter and therefore put the patient back on.
 
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Brand NameIAG BC PRO GLOBAL PNK 20GA X 1.0IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key12270656
MDR Text Key264973605
Report Number1710034-2021-00654
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381033
Device Lot Number0132442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2020
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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