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

Catalog Number	LH-0035
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that there was no discomfort during the puncture, and it was performed smoothly.The patient went home with the puncture still in place.When he returned to the hospital to have it removed, the safety device did not activate.The needle was not retracted.No further information 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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
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 activating the safety mechanism is unconfirmed because the problem could not be reproduced.One 22 ga x 0.50 in.Safestep infusion set was returned for evaluation.An initial visual observation of the returned infusion set revealed use residues throughout the device.The base of the needle shaft was observed to be slightly angled.No other damage was observed on the device.A functional test of attempting to advance the safety mechanism over the needle tip revealed little resistance, and the safety mechanism was able to completely cover the needle tip without difficulty.The slight angle of needle may have contributed to difficulty activating the safety mechanism during attempted use.However, the safety mechanism functioned as intended during evaluation.Therefore, the complaint of difficulty activating the safety mechanism could not be confirmed.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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22292406
• Report Number: 3006260740-2025-04055
• Device Sequence Number: 15685714
• Product Code: FPA
• UDI-Device Identifier: 00801741066283
• UDI-Public: (01)00801741066283(11)250203(17)270717(10)ASJUFC078
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153440
• 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
• Report Date (Section B): 07/14/2025

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 Catalogue Number: LH-0035
• Device Lot Number: ASJUFC078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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