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	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported safe step needle 22g, 1.0 inch was attempted on patient and then discontinued from patient as safety mechanism did not activate.No further information was 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 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 defective safety mechanism is confirmed and was determined to be use-related.One 22 ga x 1.0 in safestep infusion set was returned for evaluation.An initial visual observation revealed the infusion set was returned with the safety mechanism detached from the needle.The needle appeared to be bent in two different locations away from the base.A microscopic observation revealed scratches proximal to the needle bevel and biological residue within the safety mechanism.The needle tip appeared to be slightly deformed.The needle cannula and the metal sleeve of the safety mechanism were measured.The needle was observed to be within the specification; however, the metal sleeve on the safety mechanism was slightly above the specification by 0.00575 mm.Because the metal sleeve was found to be minimally above specification, as well as the bent needle and scratches found on the needle shaft, it is reasonable to suggest that the metal sleeve could have been enlarged due to an attempt to forcibly advance the safety mechanism over the bent needle.It is likely that advancement of the safety mechanism over the bent needle caused the safety mechanism to become damaged and contributed to the detachment of the safety mechanism.Force applied at an angle to the needle axis, or if the needle is not inserted perpendicular into the port septum, can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.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: 24383906
• Report Number: 3006260740-2026-00938
• Device Sequence Number: 10208283
• Product Code: FPA
• UDI-Device Identifier: 00801741066191
• UDI-Public: (01)00801741066191
• 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
• Report Date (Section B): 04/06/2026

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-0030YN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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