MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD SAFESTEP; 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	11/04/2025
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 device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.
Event or Problem Description
It was reported flushing through the port needle when a drop comes out of the blue screw connector/one-way valve on the tubing.It was only nacl this time, no further 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 leaking y-site is confirmed.One 20ga x 1.0 in.Safestep infusion set was returned for evaluation.An initial visual observation showed use residue on the returned sample.No damage was observed on the valve of the y-site and no cracks were found in the y-site or the proximal luer hub.The sample was flushed and pressurized with a 12 ml syringe of water and no leakage was found.A droplet of water was observed to form near the valve of the y-site when the sample was pressurized; however, no continuous dripping or leaks were observed.The blue stem of the valve can move slightly according to the pressure to which it is exposed.Any fluid that is positioned between the blue valve stem and the white valve housing can be pushed out from the white valve housing under a positive pressure.The product ifu warns: ¿needleless y-injection site valve may leak slightly at certain pressures resulting in a small bead of fluid on the valve.¿ this complaint will be recorded for future trending and monitoring purposes.

• Brand Name: BARD SAFESTEP
• 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 84116
• Manufacturer Contact: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23655777
• Report Number: 3006260740-2025-09069
• Device Sequence Number: 4770465
• Product Code: FPA
• UDI-Device Identifier: 00801741066252
• UDI-Public: (01)00801741066252
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: UNK
• 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): 01/13/2026

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/14/2026
• 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