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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 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 0671910
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem Chemical Exposure (2570)
Event Date 10/09/2023
Event Type  malfunction  
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 device has not been returned to the manufacturer for evaluation.
 
Event Description
It was reported by the customer that "we have a leak from our port needle.The patient came to have pump disconnected today on (b)(6) 23.Prior to disconnecting the nurse noticed a moderate amount of white powder and leakage from the end of the tubing site away from the needle area where the micro-clave cap and tubing connects.Patient received medication but with the white powder, patient can be exposed to chemo leakage to skin.".
 
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 complaint of a crack in the y-site was confirmed as supplier related.The returned sample was found to exhibit the same features as a known issue, and the root cause was determined to likely be within the scope of the known issue.The returned product was a 19g x 1¿ powerloc safety infusion set.The y-site luer adaptor contained a longitudinal crack traversed from the orifice of the connector to the mold indicator.The crack in the y-site luer adaptor leaked when the sample was flushed.This event was likely related to a known supplier related issue.This complaint will be recorded for future trending and monitoring purposes.
 
Event Description
It was reported by the customer that "we have a leak from our port needle.The patient came to have pump disconnected today on 10-9-23.Prior to disconnecting the nurse noticed a moderate amount of white powder and leakage from the end of the tubing site away from the needle area where the micro-clave cap and tubing connects.Patient received medication but with the white powder, patient can be exposed to chemo leakage to skin.".
 
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Brand Name
POWERLOC SAFETY INFUSION SET 19G X 1 IN 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
suedabba mahboobi
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key18016900
MDR Text Key326722514
Report Number3006260740-2023-04891
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741047893
UDI-Public(01)00801741047893
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 User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0671910
Device Lot NumberASGZFC029
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2022
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;
Patient Age63 YR
Patient SexMale
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