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

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported leakage from a safety port needle.Replaced the infusion port needle and applied a new dressing.
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.
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 infusion set was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 0.75¿ powerloc safety infusion set with y-site.Light usage residues were observed throughout the sample.A dead end cap was attached to the proximal luer adapter and the safety mechanism was engaged.Microscopic inspection of the proximal luer adapter revealed abundant superficial stress fracturing throughout the threaded region.Thread deformation and mechanical damage were also observed.A complete fracture was observed near the finger tab opposite the gate mark from the molding process.The mechanical damage was consistent with manipulation of the luer using a grasping instrument such as pliers or hemostats, suggesting that overtightening of the luer connection likely contributed to the observed damage.The abundant superficial fracturing further suggested that an additional unidentified environmental factor(s) affected the mechanical properties of the luer adapter.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: POWERLOC
• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23542233
• Report Number: 3006260740-2025-08626
• Device Sequence Number: 13092037
• Product Code: FPA
• UDI-Device Identifier: 00801741048425
• UDI-Public: (01)00801741048425(11)230823(17)261219(10)ASHTFS028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 8672034
• Device Lot Number: ASHTFS028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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