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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned four devices to the manufacturer and all four were found to have plastic broke off the end caps.This report addresses all four devices.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The failure was found during evaluation of a returned sample.Additional investigation is required to determine the cause of the failure.Results of the investigation are expected soon.
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 foreign material within the luer hubs is confirmed and was determined to be supplier related.Four 19 ga x 1.0 in.Safestep infusion sets with y-sites were returned for evaluation.An initial visual observation of the returned infusion sets revealed no obvious use residues throughout the returned devices.Microscopic observation of the white luer caps revealed each luer cap was observed to be damaged.White material which appears to be from the luer caps was found within the proximal luer hub of each of the returned infusion sets.It was determined that the observed damage was related to the manufacturing process of the devices.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 UT 84116
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21754127
• Report Number: 3006260740-2025-01958
• Device Sequence Number: 18208721
• Product Code: FPA
• UDI-Device Identifier: 00801741066276
• UDI-Public: (01)00801741066276(11)240717(17)270308(10)ASJQFC044
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 06/25/2025

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-0034YN
• Device Lot Number: ASJQFC044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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