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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 0671934J
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. Review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the powerloc was accessed to a port system on (b)(6) 2021. On (b)(6) 2021, during high pressure infusion of contrast medium, the cap of the luer connector of y-site was detached and contrast medium leaked. There was no reported patient injury.
 
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Brand NamePOWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key11713535
MDR Text Key247217415
Report Number3006260740-2021-01478
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0671934J
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 Received03/30/2021
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

Patient Treatment Data
Date Received: 04/23/2021 Patient Sequence Number: 1
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