MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported, that port accessed and huber needle leaking at connection site to cap.Attempted to change cap, but still leaking.Port de-accessed and new needler use.No patient harm.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 complaint of a leak was confirmed, but the root cause could not be determined.The product returned for evaluation was one 20g powerloc infusion set.An injection cap was returned attached to the luer of the infusion set.The returned unit was leak tested by flushing the infusion set with water using a 12ml luer lok syringe.During testing, a leak was observed at the interface between the returned injection cap and the infusion set luer.The unit was tested again twice, once with a representative injection cap and once with a direct connection to the luer lok syringe.In both instances, the unit was found to leak at the luer, indicating that the leak was being caused by the infusion set and not by any device being attached to it.Microscopic inspection of the infusion set luer found that a portion of the inner luer wall was damaged.The damage extended to the proximal end of the luer.Around the edges of the damaged segment, the luer wall material was frayed.It is likely that the observed damage prevented an adequate fit to occur between the luer and the injection cap, thus, creating a path for liquid to flow through.However, based on the available evidence, it could not be conclusively determined when or how the damage occurred.Therefore, the root cause remains unknown.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that port accessed and huber needle leaking at connection site to cap, attempted to change cap but still leaking.Port de-accessed and new needler use.No patient harm.No other information was provided.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20753116
• Report Number: 3006260740-2024-06888
• Device Sequence Number: 8587599
• Product Code: FPA
• UDI-Device Identifier: 00801741047763
• UDI-Public: (01)00801741047763(11)240812(17)270724(10)ASJNFC129
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/31/2025

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: 0652034
• Device Lot Number: ASJNFC129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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