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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of asfqf041 showed two other similar product complaint(s) from this lot number. The complaints for this lot number (asfqf041) have been reported from the same facility.
 
Event Description
It was reported "there was a break in the tubing connected to the huber needle. The break was closer to the end of the tubing near the microclave. " no other information was provided.
 
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Brand NamePOWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
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 Key12686696
MDR Text Key278080808
Report Number3006260740-2021-04506
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153440
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 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0142075
Device Lot NumberASFQF041
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 Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
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: 10/23/2021 Patient Sequence Number: 1
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