MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "i have a port needle with y-site that leaked at the connector y-site.This area has notable white powder on the tubing and connector and is not site where the chartwell pump tubing was connected to." no other information was provided.
Additional 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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Additional 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 leaking y-site was confirmed.The product returned for evaluation was one 19g powerloc infusion set w/y-site.A gross visual inspection of the returned unit found that two injection caps were returned attached to the two luers of the infusion set.The unit was leak tested by flushing water through each of the injection caps using a 12ml luer lok syringe.During testing, no leaks were observed.The same leak test was performed, except with the clamps engaged to simulate pressurization.A leak was then observed between the injection cap and the luer of the y-site.The injection cap was inspected and found to be loosely attached to the luer.The injection cap was tightened and the pressurized leak test performed again.No leaks were observed.Finally the unit was leak tested with and without pressurization by connecting the luer lok syringe directly to the luer of the infusion set and no leaks were observed again.Based on the available evidence, the reported leak was present but was caused by inadequate tightening of the injection cap.
Event or Problem Description
It was reported by the customer "i have a port needle with y-site that leaked at the connector y-site.This area has notable white powder on the tubing and connector and is not site where the chartwell pump tubing was connected to." no other information was provided.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE
• Common Device Name: 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18412788
• Report Number: 3006260740-2023-05908
• Device Sequence Number: 2673539
• Product Code: FPA
• UDI-Device Identifier: 00801741047893
• UDI-Public: (01)00801741047893
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0671910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown