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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 0652034
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.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 by the facility that the pressure was limited coming from two needles, stating it measured at only 250 psi.Facility had to use a new port access needle to finish procedure.This report addresses needle two.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of limited pressure is inconclusive due to unknown clinical conditions.Two 20 ga x 0.75 in powerloc infusion sets were returned for investigation.The safety mechanisms were returned fully activated.The samples were flushed with water using a 12 ml syringe and no apparent resistance was felt.A guidewire was passed through the needle and no obstructions were observed.Based on the description of the reported event, possible contributing factors include partial occlusion within the port and equipment used.As no resistance was observed during infusion and the flow path appeared to be clear of obstructions, the complaint is inconclusive due to unknown clinical conditions.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 by the facility that the pressure was limited coming from two needles, stating it measured at only 250 psi.Facility had to use a new port access needle to finish procedure.This report addresses needle two.
 
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Brand Name
POWERLOC SAFETY INFUSION SET 20G X 0.75IN
Type of Device
SET, 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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7807792
MDR Text Key118111198
Report Number3006260740-2018-02184
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741047763
UDI-Public(01)00801741047763
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0652034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/22/2018
Supplement Dates Manufacturer Received08/23/2018
Supplement Dates FDA Received09/21/2018
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 Sequence Number1
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