MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 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	10/29/2025
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The complaint of a leak at the y-site valve was confirmed.Five 22ga x 0.75 in safestep infusion sets were returned for evaluation.An initial visual observation revealed the samples were returned sealed.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 samples were flushed with a 12 ml syringe of water and no leakage was found.The distal pinch clamp of the infusion sets was then engaged, and the samples were pressurized with the 12 ml syringe of water from the proximal luer hub.A droplet of water was observed to form near the valve of the y-site when the samples were 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.
Event or Problem Description
It was reported that there was leakage happened in medegen needleless injection cap in safestep huber needle set lh-0029yn during flushing.The flushing saline was back flow in needleless injection cap.Additional unopened samples were received.During functional testing, a droplet of fluid was noted on the valved y-site.It was reported this occurred with 5 devices.This report addresses all 5 devices.

• Brand Name: 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 UT 84116
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23543899
• Report Number: 3006260740-2025-08636
• Device Sequence Number: 9776003
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177(11)221219(17)250929(10)ASGWFC131
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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 Expiration Date: 09/29/2025
• Device Model Number: N/A
• Device Catalogue Number: LH-0029YN
• Device Lot Number: ASGWFC131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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