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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that having difficulty pulling the transparent tegaderm dressing off the port access needles when they need to remove the needles from the port.Recently, a nurse was stuck with a needle while attempting to remove the tegaderm dressing.No further details provided.
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
Additional information received 28 jan.2026.The kits were supposed to have the ballooned dressing that does not stick to the hub of the needle.Instead, the dressing was substituted with a regular tegaderm with chg, which stuck to the entire huber needle and would not allow the safety to engage.The nurse was peeling the dressing off when the needle came out of the patient and she was stuck.The patient did not have any blood borne diseases, but blood work was completed for the nurse as a precaution.There was no long term 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.

• Brand Name: ALLPOINTS 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24277323
• Report Number: 3006260740-2026-00639
• Device Sequence Number: 8579835
• Product Code: PTI
• UDI-Device Identifier: 00801741119316
• UDI-Public: (01)00801741119316(11)251110(17)261231(10)REKX1055
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AN142075G
• Device Lot Number: REKX1055
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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: Required Intervention
• Patient Sex: Unknown