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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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.The manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer, "patient at home for a home parental nutrition notified our unit that the needle broke into pieces whilst trying to de access her port (we have been told by the patient that her mum accesses and de accesses the port).She removed the broken needle herself and was then advised to attend emergency to have the port assessed and be scanned by interventional radiology.She did and was cleared and discharged home with nil ill outcome.".
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 a damaged infusion set needle was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 22ga x 0.5¿ safestep safety infusion set with y-site.A complete break was observed in the needle shaft 6mm from the needle housing.The needle tip fragment and safety plate were received loose.Microscopic inspection of the break site revealed a granular fracture surface.Necking and curved shape memory were observed in the vicinity of the break.Regions of increased luster were observed along the fracture edges.A similar non-complainant device was intentionally damaged by repetitively kinking the needle shaft at the exit site from the non-engaged safety mechanism.Inspection of the fracture features revealed them to match those observed in the complaint sample.The location of the fracture also matched that of the complaint sample.The fracture features and location were replicated by kinking the needle shaft, suggesting that repetitive kinking of the indwelling needle shaft likely caused/contributed to the observed damage.Infusion set securement techniques may have contributed.

• 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: carey carter ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21649614
• Report Number: 3006260740-2025-01644
• Device Sequence Number: 18014774
• Product Code: FPA
• UDI-Device Identifier: 00801741066283
• UDI-Public: (01)00801741066283(11)230503(17)260217(10)ASHPFC130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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 Expiration Date: 02/17/2026
• Device Model Number: N/A
• Device Catalogue Number: LH-0035
• Device Lot Number: ASHPFC130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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