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

Catalog Number	AN652034G
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the patient was given a sentrinex dressing during a port access procedure.During the process of going home and returning to the infusion center, the dressing lifted.When the patient returned, the dressing was not occlusive.No further information was 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.
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 the dressing failing to adhere is confirmed; however, the exact cause is unknown.Two photographs of a sentrinex dressing were returned for evaluation.An initial visual observation of the first photograph showed a sentrinex dressing lifting from the patient¿s skin on all sides.Five additional pieces of tape were observed securing the dressing to the patient.The sentrinex dressing appeared to be placed as directed over the needle, with the tubing extending from the bottom of the dressing.It is unknown if any site preparation was used to assist adhesion before applying the dressing.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
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.

• Brand Name: PORT ACCESS DEVICES, POWER INJECTABLE, POWERLOC, ALLPOINTS DRESSING 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22020425
• Report Number: 3006260740-2025-03123
• Device Sequence Number: 15800430
• Product Code: FPA
• UDI-Device Identifier: 00801741215452
• UDI-Public: (01)00801741215452(11)241004(17)260131(10)REJV1643
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• 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,Followup
• Report Date (Section B): 07/01/2025

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: 01/31/2026
• Device Catalogue Number: AN652034G
• Device Lot Number: REJV1643
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 07/01/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/29/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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