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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 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 8652034
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of asdys0042 showed three other similar product complaint(s) from this lot number.
 
Event Description
It was reported before performing the maintenance of the infusion port for the patient, routinely flush the infusion tube needle and find that the pipeline is blocked.
 
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Brand NamePOWERLOC SAFETY 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)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key11644947
MDR Text Key244873431
Report Number3006260740-2021-01263
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8652034
Device Catalogue Number8652034
Device Lot NumberASDYS0042
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 Received03/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2019
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: 04/09/2021 Patient Sequence Number: 1
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