MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX; PORT ACCESS NEEDLE

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	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "patient was running a blood transfusion through his ivad.At the end of the infusion, patient notified rn that he had blood on him.Rn paused infusion and checked tubing, connection between tubing and microclave cap, and connection between microclave cap and line.The leakage was noted to be between the microclave cap and the line.Provider notified.No patient harm, injury, complication, or negative outcome as a result.Our team is not sure if this is a connection issue between the hub at the distal end of the ivad tubing or with the microclave somehow.The patient was accessed, flushed, blood infusion and when it was finishing up blood was leading out of the connection of microclave/hub.It does not appear to be leaking from below the hub/where the cracks were occurring in the previous ivad product.".
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 it will be evaluated.A supplemental will be submitted with evaluation results.
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 could not be confirmed.The product returned for evaluation was one 20g powerloc max infusion set w/o y-site.A gross visual inspection of the returned unit found no damage or defects to the components.The unit was leak tested by flushing the infusion set with water using a luer lock syringe.No leaks were observed during testing.The infusion set female luer and injection cap male luer were tested with a pass/fail gauge.Both luers were found to be within specification.Based on the available evidence, the reported defect could not be confirmed.

• Brand Name: POWERLOC MAX
• Common Device Name: PORT ACCESS NEEDLE
• 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 UT 84116
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22323807
• Report Number: 3006260740-2025-04258
• Device Sequence Number: 12964872
• Product Code: FPA
• UDI-Device Identifier: 00801741047466
• UDI-Public: (01)00801741047466(11)250306(17)280216(10)ASKPFC081
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 0142075
• Device Lot Number: ASKPFC081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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