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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that upon ejection of catheter, wire was stuck and not able to be pulled out without removing catheter.Had to re-stick with another accucath.No further details available or provided.
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 catheter insertion is confirmed; however, the exact cause is unknown.One photograph of a 20 ga accucath ace was returned for evaluation.An initial visual observation of the photograph showed abundant blood residues inside the catheter and the catheter hub of the accucath ace device.The catheter was observed to be detached from the accucath ace device housing and guidewire.The distal end of the catheter appeared flared and deformed, and two kinks were observed along the distal end of the catheter shaft.The needle appeared to be properly inside the housing of the accucath ace device as the safety mechanism appeared to engage successfully.An observation of the guidewire of the accucath ace showed the coiled tip of the guidewire.The quantity of coils at the distal tip of the guidewire could not be counted from the returned photograph, as the distal end of the guidewire appeared blurry.No other features of the guidewire or catheter could be discerned from the returned photograph.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause of difficult catheter insertion.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: ACCUCATH ACE
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24152289
• Report Number: 3006260740-2026-00131
• Device Sequence Number: 9486812
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010(11)250826(17)261130(10)REKU2250
• 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,Followup
• Report Date (Section B): 03/13/2026

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 Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REKU2250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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