MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTRAVASCULAR CATHETER (20G); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that after inserting an accucath 20g 2.25 inch catheter, it would not flush.Nurse attempted to remove and when almost completely out, catheter could not be removed from the vein/skin.Surgeon called to remove so as not to damage catheter.Surgeon able to pull out and the tip of catheter was kinked.Additional information 07/25/2024: it was reported by the customer "the patient did not have catheter removed surgically.The surgeon was able to pull it out.I am not aware if the patient had any subsequent adverse event.".
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 it will be evaluated.A supplemental will be submitted with evaluation results.
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 kink in the catheter is confirmed; however, the exact cause is unknown.Two photographs of an accucath were returned for evaluation.An initial visual observation of one of the photographs showed a bend near the distal end of the catheter.Evidence of use was observed on the catheter.There were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that after inserting an accucath 20g 2.25 inch catheter, it would not flush.Nurse attempted to remove and when almost completely out, catheter could not be removed from the vein/skin.Surgeon called to remove so as not to damage catheter.Surgeon able to pull out and the tip of catheter was kinked.Additional information 07/25/2024: it was reported by the customer "the patient did not have catheter removed surgically.The surgeon was able to pull it out.I am not aware if the patient had any subsequent adverse event.".

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER (20G)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19977163
• Report Number: 3006260740-2024-04432
• Device Sequence Number: 8460814
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010(11)240513(17)250831(10)REJR0456
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/11/2024

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: AC1202252
• Device Lot Number: REJR0456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 12/06/2024
• 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