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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 Erythema (1840)
Event Date 05/01/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. 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 "the patient had a port placed in the or on 4/30. On 5/1 after the third dose of mesna, the patient's dad noticed that there was blood on the patient's hospital gown. Upon looking at the port dressing, there was blood and fluid within the port dressing as if the port was leaking. Rn flushed the port and got great blood return when assessing the port dressing (i checked this patient's port for blood return with labs at 0900, one other time between 1000-1300 because the mivf running alarmed "line occluded", and again when assessing this port leakage situation). When flushing the port, it looked like some ns was leaking into the dressing. I stopped the mivf that was running and asked for help. We thought maybe the port needle tubing was broken so we de-accessed and re-accessed the patient. The patient's port site looked fine, no sign of infiltration or bogginess, it was just a little bit red around the port needle site. It was noted that the patient's port was not steri-stripped down so when the patient was re-accessed we made sure to use steri-strips. " "we saved the port needle tubing but could not find a breakage in the tubing. It seems that when it is flushed, the fluid only comes out of the port needle and is not leaking anywhere else throughout the tubing. ".
 
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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 Key12182113
MDR Text Key262023256
Report Number3006260740-2021-02786
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 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
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 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 Received06/22/2021
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: 07/16/2021 Patient Sequence Number: 1
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