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	06/18/2025
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 complaint of a leak was confirmed.The product returned for evaluation was one 20g safestep infusion set w/ valved y-site.A gross visual inspection of the returned unit found that three areas of deformation were present on the white piece of the y-site housing.One on the distal end of the luer threads, one below the damaged area on the luer threads, and one on the distal end of the white piece.Microscopic inspection of the deformed areas found that the area at the distal end of the white piece was missing material and striation markings were present on the surface, suggesting that the material had been sheared off.The other two damaged areas still had all the material present but it had been deformed such that it appeared as if it had been pushed out of the way.No other damage or markings were observed throughout the infusion set.The unit was leak tested by flushing the proximal luer hub and y-site with water using a 12ml luer lock syringe.During testing, a leak was observed on the y-site housing, between the white and clear piece of the housing.The site of the leak was near one of the areas of deformation observed.The features observed suggested that the damage to the white piece of the y-site housing may have caused a gap to form internally in the y-site.Additionally, the lack of additional damage surrounding the deformed areas suggested that the device was not mishandled during use and instead the damage originated during product manufacture.The device is a supplied component and the supplier was notified of the event.This complaint will be recorded for future trending and monitoring purposes.
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.
Event or Problem Description
It was reported by the customer liquid leakage from the plastic plate during infusion therapy.

• 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 84116
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22468123
• Report Number: 3006260740-2025-04659
• Device Sequence Number: 14521148
• Product Code: FPA
• UDI-Device Identifier: 00801741066238
• UDI-Public: (01)00801741066238(11)240708(17)270708(10)ASJUFC025
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153440
• 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): 08/19/2025

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: LH-0032YN
• Device Lot Number: ASJUFC025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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