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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
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.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.
Event or Problem Description
It was reported by customer that it was leaking occurred at the connector site.After starting hydration on patient via port, leaking occurred at the connector site.Reached the individual but did not cause 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 complaint of a leaking luer hub connection is confirmed.One 20 ga x 0.75 in powerloc max infusion set and a non-bd needleless injection cap were returned for evaluation.An initial visual observation showed use residue on the returned samples.A needleless injection cap was attached to the luer hub, and the safety mechanism was observed to be engaged.A functional test of flushing water through the infusion set using a 12 ml syringe was performed and a leak was found between the luer hub and the injection cap connection.The infusion set luer hub was then tested with a female iso luer taper gauge and the inner diameter of the luer hub was found to be within specification.The needleless injection cap was also tested using a male iso luer taper gauge and appeared to be out of specification.The manufacturer of the needleless injection cap was notified about this issue.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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24565286
• Report Number: 3006260740-2026-01519
• Device Sequence Number: 20974527
• Product Code: FPA
• UDI-Device Identifier: 00801741044298
• UDI-Public: (01)00801741044298(11)251027(17)270228(10)REKW0452
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 2142075
• Device Lot Number: REKW0452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2025
• 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