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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by medwatch rn (registered nurse) gathered her supplies to access the patients port for his treatment.When the rn took off the white end cap from the end tubing of the huber needle, she noted a tiny piece of white on the inside of the end tubing.She turned the end of the tubing over and the tiny white piece came out, it felt hard to the touch, questioning if it was a piece of plastic.When examining the white end cap, it looked like it had a small divit on it, like it was missing a piece of plastic.These items were set aside, not used for port access.Huber needle, end cap, and packaging given to rn manager.A different huber needle obtained, no issues noted with it and was used to access the patients port for treatment.No patient harm.
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 device has not been received by the manufacturer for evaluation.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.

• 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 garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21903857
• Report Number: 3006260740-2025-02569
• Device Sequence Number: 8821764
• Product Code: FPA
• UDI-Device Identifier: 00801741066238
• UDI-Public: (01)00801741066238(11)240926(17)270926(10)ASJWFC119
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/09/2025

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-0032YN
• Device Lot Number: ASJWFC119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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 Age: 68 YR
• Patient Sex: Unknown