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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS 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 Problems Extravasation (1842); Infiltration into Tissue (1931)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported inpatient 5th floor identified another leak that resulted in an extravasation. (lot number 552149 port kit). 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)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key9592940
MDR Text Key190780900
Report Number3006260740-2020-00104
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 company representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0142075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/20/2020
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
Removal/Correction Number2243072-06/03/2020-006-R

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