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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 WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problems Infiltration into Tissue (1931); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asdqs0196 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that when ct examination was performed, contrast medium leaked from the port body during infusion with contrast medium using powerloc.When the ct was checked, no contrast medium was infused into the port body, and there was leakage outside the port body, so there was a possibility that it leaked due to the procedure.It was stated since the needle was visible at the end of the port body by ct, the needle did not reach the inside of the port bottom, leading to leakage.There was no reported patient injury.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety infusion set with y-site.Usage residues were observed throughout the sample and an extension set was attached to the luer adapter.The safety mechanism was not engaged.Microscopic inspection of the sample did not reveal any evidence of current or previous leakage.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.Based on the event description, potential contributing factors to the reported event include not inserting the infusion set needle fully into the port reservoir prior to aspiration/infusion.
 
Event Description
It was reported that when ct examination was performed, contrast medium leaked from the port body during infusion with contrast medium using powerloc.When the ct was checked, no contrast medium was infused into the port body, and there was leakage outside the port body, so there was a possibility that it leaked due to the procedure.It was stated since the needle was visible at the end of the port body by ct, the needle did not reach the inside of the port bottom, leading to leakage.There was no reported patient injury.
 
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Brand Name
POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
Type of Device
SET, 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
kelsey erickson
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key13482489
MDR Text Key285326810
Report Number3006260740-2022-00200
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060812
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 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0672034J
Device Lot NumberASDQS0196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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