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

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Erythema (1840); Infiltration into Tissue (1931); Swelling/ Edema (4577)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the patient's sentrinex dressing had lifted.The patient experienced infiltration.No other 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.The device has not been received by the manufacturer for evaluation.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.
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 dressing failed to adhere is confirmed; however, the exact cause is unknown.Eight photographs of a sentrinex dressing were returned for evaluation.An initial visual observation of the photographs showed two photographs of tape securing the dressings to the patient, and a collection of 6 photographs of what appears to be the dressing adhesion failing to adhere and skin condition.The photographs appear to be of four patients.The four distinct devices were observed to have various amounts of detachment.One patient¿s port needle was observed to be dislodged and tilted to one side as a result of the dressing failing to protect the device.All four dressings appeared to be applied as directed over the needle with no obvious cause of detachment found.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.
Event or Problem Description
Additional information (b)(6) 2025: patient was receiving 5fu, infiltration resulted in swelling and mild erythema.No medical intervention needed for infiltration; infusion was prolonged as new infusion had to be mixed.Port re-accessed, blood return noted and flushed.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22136243
• Report Number: 3006260740-2025-03603
• Device Sequence Number: 20964015
• 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
• Report Date (Section B): 07/02/2025

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 Model Number: N/A
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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