MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTRAVASCULAR CATHETER 22GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
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 by customer that "when she went to deploy the catheter this part also deployed.¿ the nurse placing the device stated that when she went to retract the needle/wire it felt like something got hung up, and when looking at the device after removal noted the plastic piece that they had never noticed before.It was noted after use/placement.No impact as the patient did not need to be restack for iv access.No adverse event or serious injury reported to patient.
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 a loose plastic piece is confirmed, but the root cause could not be determined.One 22 ga accucath ace was returned for evaluation.An initial visual observation of the returned photograph of the accucath ace showed blood use residues throughout the device.The safety mechanism of the device was engaged upon return of the device, and the guidewire was observed to be completely advanced.A microscopic observation revealed when the plastic portion was compared to a non-complainant device, it was observed that the plastic piece was supposed to be inside the luer of the catheter, but the catheter was not returned for evaluation.The plastic portion found along the guidewire was observed to be the flow actuator from the luer of the catheter.No obvious damage was observed along the plastic.Due to the nature of the catheter not being returned for evaluation, the cause of the plastic coming loose from the catheter luer remains unknown at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER 22GX1.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 20570643
• Report Number: 3006260740-2024-06339
• Device Sequence Number: 8226707
• Product Code: FOZ
• UDI-Device Identifier: 00801741137938
• UDI-Public: (01)00801741137938(17)250831(10)REJR0520
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Followup
• Report Date (Section B): 03/11/2025

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: AC1221250
• Device Lot Number: REJR0520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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 Sex: Unknown