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

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that clinician encountered multiple insertion attempts while using the bd miniloc¿ huber needle set (19ga × 0.75 inches / 19 mm) without y-site inserted through septum of surgically implanted port for administration of fluids, administration of medications / drugs, and blood sampling.No other information was provided and no patient harm reported,.
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.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.The device has not been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The information provided by bd represents all of the known information at this time.This complaint was received as part of a clinical survey.Contact information and specific patient details were not disclosed as part of the survey.As such, additional information and the subject sample cannot be obtained.
Event or Problem Description
It was reported via post market survey that clinician encountered multiple insertion attempts while using the bd miniloc¿ huber needle set (19ga × 0.75 inches / 19 mm) without y-site inserted through septum of surgically implanted port for administration of fluids, administration of medications / drugs, and blood sampling.Initially no backflow was noted and the portacath area got swollen after injecting 10 mls of saline.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.

• Brand Name: MINILOC, PORT ACCESS KIT
• 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: 21407712
• Report Number: 3006260740-2025-00766
• Device Sequence Number: 15515095
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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