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

Model Number	N/A
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported health professional tried to pass water on a saline diet, but there is no way.There was no patient contact.(b)(6) 2026 it was found during an investigation an occlusion was observed at the needle housing.
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 an occluded infusion set was confirmed, but the root cause remains unknown.The product returned for evaluation was one 22g safestep infusion set without y-site.The sample was functionally tested by attempting to flush the device using water and a 12ml syringe.During testing, a partial occlusion was encountered at the needle housing.The unit was dissected and the proximal end of the needle microscopically inspected.No obstruction was visible at the proximal end of the needle, indicating that the occlusion was present deeper inside the needle.The occlusion was then attempted to be flushed out by pressurizing the needle with air and then venting it by quickly allowing the built-up air to escape.During venting, a very small clear chunk of material was ejected from the proximal end of the needle.The occluding material was probed using tweezers and the material was found to be malleable.When pressed into, the clear substance would compress, and then return to its original shape.The features of the occluding material suggested that the material may have been silicone from the septum, which may occur if the needle cores the septum; however, in this case, no biological residues were observed throughout the device, indicating that port was likely not accessed.Based on the available evidence, the cause of the occlusion was identified but it could not be determined where the occluding material originated from.Therefore, the root cause remains unknown.This complaint will be recorded for future trending and monitoring purposes.

• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 25719847
• Report Number: 3006260740-2026-04737
• Device Sequence Number: 5217633
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160(11)250827(17)280510(10)ASKSFC027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: LH-0029
• Device Lot Number: ASKSFC027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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