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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 10/24/2021
Event Type  malfunction  
Event Description
It was reported "bard needle set, the tubing cracked near the connection sleeve and my patient bled out approx. 15ml and lost some medication at well. Date of initial access with this needle was (b)(6) 2021 @ 1830. Noticed to be leaking on (b)(6) 2021 @ 2050. When attempting to re access the port, line infiltrated and became so swollen that a piv was needed to continue fluids. Micofungin was the medication infusing at the time of the leak. ".
 
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
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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 Key12911093
MDR Text Key281590490
Report Number3006260740-2021-05091
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,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
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: 12/01/2021 Patient Sequence Number: 1
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