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

Model Number	N/A
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer there was no sleeve covering the huber needle.The hcp suffered a needle stick while attaching the clave and sterile flush.The device was disposed of after the event.
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 a missing needle guard is inconclusive because the returned photographs depict the non-original sample.Two photographs of 20 g powerloc max infusion sets were returned for evaluation.Inspection of the photographs showed an infusion set in the cardstock.In one photograph, the needle guard was observed on the needle.The other photograph depicted the infusion set without the needle guard.As stated in the description of the event, the original, implicated sample was discarded.The complaint of a missing needle guard could not be confirmed due to the returned photographs depicting the non-original sample.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERLOC MAX, 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22135077
• Report Number: 3006260740-2025-03600
• Device Sequence Number: 15598913
• Product Code: FPA
• UDI-Device Identifier: 00801741119224
• UDI-Public: (01)00801741119224(11)250121(17)260430(10)REJY2528
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K073050
• 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): 07/11/2025

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: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: AN142075
• Device Lot Number: REJY2528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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