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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
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.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.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that the port access device did not fully retract needle after being de-accessed by writer, needle is still fully exposed.Prior to de-accessing, port was flushing well and was giving good blood return.No harm to patient.
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.
Event or Problem Description
Additional information received on 9/8/2025: there was no needlestick injury to the patient or to the nurse involved with the malfunctioning product.
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 difficulty advancing the safety mechanism was confirmed but the root cause could not be determined.The product returned for evaluation was one 19g safestep infusion set w/ y-site.A gross visual inspection of the returned unit found that use residues were present on the proximal end of the needle shaft.The returned unit was functionally tested by attempting to advance the safety mechanism over the needle tip.During advancement, some resistance was encountered, but with some force it was able to be fully advanced.Further inspection under a microscope found longitudinal scratch marks on the needle shaft, at the area where they safety mechanism had encountered resistance.This indicated that some interference between the sleeve and the needle shaft had occurred.Further testing, attempting to slide the safety mechanism up and down the needle, no longer encountered any resistance anywhere along the needle shaft.This potentially suggested that whatever had been causing resistance had been removed during the initial test.The safety mechanism was dissected for further inspection.Inspection of the sleeve found no residues inside the sleeve.The sleeve inner diameter was found to be slightly out of round.Since the sleeve was not symmetrical, the sleeve was attempted to be slid up and down the needle shaft while rotating it to observe if any orientation of the sleeve caused resistance with the needle.This test did not find any resistance, regardless of how the sleeve was oriented.The outer diameter (od) of the needle and inner diameter (id) of the sleeve were measured.The sleeve id was larger than the needle od, indicating that no interference between the sizing of the components was present.The features observed indicated that some interference had occurred between the sleeve and the needle shaft; however, no features were observed to indicate a specific root cause.Therefore, the root cause remains unknown.

• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22956043
• Report Number: 3006260740-2025-06544
• Device Sequence Number: 9636749
• Product Code: FPA
• UDI-Device Identifier: 00801741066252
• UDI-Public: (01)00801741066252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 10/20/2025

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-0033YN
• Device Lot 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 10/20/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/25/2025; 10/23/2025
• 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