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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, needle leaked during irrigation between the needle stabilizer and the patient's skin.Additional information received on 08/29/2025: patient treatment had to be postponed until the next day.Port re-accessed with a new needle.A specific number of affected devices or patients was not provided by the complainant.
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.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
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 leaking infusion sets is unconfirmed, as no issues were found with the returned samples during testing.Two hundred eighty-five powerloc max infusion sets were returned for evaluation.An initial visual observation revealed from the 285 infusion sets returned, 10 were packaged in a bag and had a batch number of asjvfc068, and 275 units (25 packaged in a bag and 250 distributed in 10 boxes containing 25 sets each) had a batch number asjvfc088.All 285 samples were observed to be sealed/unused, and no damage or abnormalities were observed.A functional test of flushing and pressurizing the infusion sets with water using a 12ml syringe was performed.All 10 samples from batch asjvfc068 were tested and no leaks were found.Due to the large number of units returned from batch asjvfc088, ansi/asq z1.4 tables at general inspection level ii were applied.Considering the number of returned units (275) as the lot size, 32 samples were required to be functionally tested.To increase the robustness of the test, 65 samples were tested, and no leaks of other functional defects were observed in any of the samples.Visual and functional evaluations of the returned samples did not reveal any evidence of leakage or damage in either batch.Therefore, this complaint cannot be confirmed at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23026797
• Report Number: 3006260740-2025-06861
• Device Sequence Number: 9819867
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374(11)241129(17)270813(10)ASJVFC068
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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: 0132075
• Device Lot Number: ASJVFC088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2024
• 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