MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A; 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	05/30/2025
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 complaint of difficult infusion into a catheter is confirmed and was determined to be use-related.One 20 ga accucath ace and its catheter was returned for evaluation.An initial visual observation showed abundant blood residues throughout the returned catheter.Some kinking was observed along the catheter shaft.A microscopic observation revealed the inside of the luer of the catheter to be covered in blood residues.Three significant kinks were observed along the catheter shaft from bending of the catheter.A functional test of attempting to infuse water into the luer of the catheter using a 12 ml syringe revealed the catheter was patent to infusion.The cause of the difficult infusion was determined to be related to the catheter kinking during use and insertion of the catheter.An examination of the catheter structure revealed no potential damage/defect related to the manufacture of the device.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported accucath was accurately placed in the center of the vein, there was blood return in the catheter but it would not flush.The nurse confirmed the placement with ultrasound but took the iv out because it wouldn't flush.She then tried to flush it outside of the patient and fluid was stopped in the hub.No other information was provided.08/06/2025- it was found during an investigation three significant kinks were observed along the catheter shaft from bending of the catheter.

• Brand Name: MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A
• 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: 22829841
• Report Number: 3006260740-2025-05919
• Device Sequence Number: 15844733
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010(11)250403(17)260531(10)REKP1432
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REKP1432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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