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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
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.The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported, have had several instances of the sentrinex dressing lifting.These are patients who are going home for home-infusions as well as patients sitting in the infusion center chairs for shorter infusions.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.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.
Event or Problem Description
It was reported by customer that had several instances of the sentrinex dressing included in allpoints lifting.Patient's dressing had lifted and posed an infection risk.It was reported this occurred with three patients.This report addresses all three patients.
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.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22090745
• Report Number: 3006260740-2025-03408
• Device Sequence Number: 6906288
• 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): 07/02/2025

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
• Date Returned to Manufacturer: 05/09/2025
• 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: 05/29/2025; 07/02/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/03/2025; 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