MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 ACCUCATH ACE; Midline Catheter

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, went to engage the safety on the accucath and the needle/guide wire didn't retract.Ended up having to withdraw the catheter out of the vein, but then noticed the wire looked shorter and the curly cue at the end of the wire was not there.Provider is aware.X-ray is ordered.Didn't pull the wire back, wire was intact out of the package, and no resistance.When i hit the retract button, the portion you hold while inserting (the see through part) was pulled out of my fingers and pulled down to the patient.At that point the whole system was stuck but the portion you hold would slide backwards but the needle still would not retract.The needle all of the sudden did retract and then i noticed it didn't appear intact and pulled the catheter out.Additional information received on 24-jul-2026: no harm that we are aware of.Inserter acted quickly and appropriately in notifying the ed providers about the concern and further interventions.The patient had an x-ray of his forearm which showed a retained fragment.Vascular was consulted and the patient had an ultrasound/vascular study which did not show any fragmentation in the vasculature.The patient was admitted, the admitting providers were aware of the concern, and the patient was followed for 2 days without further complications/concerns.
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.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50141138
• Report Number: 3006260740-2026-05505
• Device Sequence Number: 18419604
• Product Code: FOZ
• UDI-Device Identifier: 00801741137952
• UDI-Public: (01)00801741137952(11)260417(17)270630(10)RELP2803
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• 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): 07/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC1202250
• Device Lot Number: RELP2803
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2026
• 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: Required Intervention
• Patient Sex: Unknown