MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERMIDLINE; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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 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.
Event or Problem Description
It was reported by medsun we were called to icu to place midline in patient.Due to some skin breakdown during our assessment myself and my coworker decided to use left arm for placement.After several unsuccessful attempts to access vein in left arm, we decided to switch nurses, and i would try to get access to place line.I was finally able to access vein and thread the wire through the needle, but the wire would not thread into the vein.This is a common complication with some line placements.When the wire would not advance in the vein i tried to pull the wire back and remove so we could make another attempt, but i met with resistance in sliding wire out of vein.Because i felt i risked a needle stick with the needle still in place around the wire i slid the needle off wire, and this left just the wire in the patient vein.I had difficult time adjusting or moving the wire as it felt like it was hung up on something inside the arm/vein.I was finally able to get the wire to move in the arm, got it most of the way out and it got hung up on something again, but i was close to the surface of the skin by this time.I took my blade and made a very small incision in the skin around the wire and was able to move the wire free.When the wire was outside the patient, i could see that a small knot had formed in the tip of the wire which was preventing in from sliding in or out easily, the patient did not seem to be affected or bothered by this action to remove wire.I have been placing lines for 15 years and have never seen this happen and cannot understand how such a thing could have occurred.

• Brand Name: POWERMIDLINE
• Common Device Name: MIDLINE CATHETER
• 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: 22322188
• Report Number: 3006260740-2025-04234
• Device Sequence Number: 8923963
• Product Code: PND
• UDI-Device Identifier: 00801741108754
• UDI-Public: (01)00801741108754(11)241203(17)260430(10)REJY0526
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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
• Report Date (Section B): 06/13/2025

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: P4154108
• Device Lot Number: REJY0526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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 Age: 77 YR
• Patient Sex: Male