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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
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 returned to the manufacturer for evaluation, as the device was discarded after the event occurred.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 placing a midline on (b)(6) 2025, while pushing the guidewire down, it suddenly stopped after being several cm past the tip of the needle.When i went to pull it out to readjust, i found that i couldn¿t.The guidewire was stuck in the needle.Using the ultrasound, i saw nothing unusual.I removed both the needle and guidewire at the same time and went ahead with my second attempt, using a separate needle and guidewire.I had no issues on my second attempt.After the procedure was completed, i noted a small burr on the guidewire where it had caught on the needle.The product was discarded.

• Brand Name: MIDLINE CATHETER KIT
• 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: 23025385
• Report Number: 3006260740-2025-06855
• Device Sequence Number: 18596954
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003(11)250407(17)260131(10)REKP1334
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2025

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: S4153108BDP
• Device Lot Number: REKP1334
• 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: 08/26/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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