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

Model Number	N/A
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer upon opening the box with 5 port access kits, they appeared to have already been breached and tampered with.With the attached syringe, they also appeared bent and with damaged push down plunge.The box they came in was not damaged and was sealed with no signs of loose tape.The item was caught before reaching the floor and did not affect patient care.This report addresses all 5 port access kits.
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.
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 damaged kit packaging and kit components is confirmed; however, the exact cause is unknown.Four photographs of powerloc max port access kits were returned for evaluation.An initial visual observation of the photographs showed a least four open kits packages and two saline syringes with bent and damaged plungers.While the packages were observed to be opened and the syringes were observed to be damaged, there were no distinguishing features in the returned photographs of the kits which could aid in identification of a specific root cause.Therefore, the root cause of the damaged kits and components is currently unknown.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC MAX, PORT ACCESS 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22205315
• Report Number: 3006260740-2025-03870
• Device Sequence Number: 15384322
• Product Code: FPA
• UDI-Device Identifier: 00801741044298
• UDI-Public: (01)00801741044298(11)250225(17)260630(10)REKN0633
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/08/2025

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 2142075
• Device Lot Number: REKN0633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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