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	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the insertion was fine without any issue.Visualized within the vein, advanced the guidewire without any problem.The vessel itself was a nice healthy, large and easily compressible vein.When they pushed the safety button, the button depressed but did not retract the needle.They said they were still parallel to the patient's arm/vein so it should have retracted easily as they normally do.They had to pull the entire needle out of the catheter in order for it to retract.No other information was 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 manufacturer has received the sample and will evaluate.Results are expected soon.
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 needle retraction failure was inconclusive.The product returned for evaluation was one 20g accucath ace needle assembly.The catheter assembly was not returned for evaluation.A gross visual inspection of the returned unit found that the needle and guidewire were fully retracted.Use residues were observed throughout the unit and the guidewire was noted to have a slight bend.The unit was functionally tested by un-retracting the needle, threading a catheter from a representative unit over the needle/guidewire, inserting the catheter into mock skin, and then retracting the needle.The needle fully retracted without resistance.No further conclusions could be drawn regarding the reported event as the returned unit was unable to be tested with its respective catheter assembly.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, the insertion was fine without any issue.Visualized within the vein, advanced the guidewire without any problem.The vessel itself was a nice healthy, large and easily compressible vein.When they pushed the safety button, the button depressed but did not retract the needle.They said they were still parallel to the patient's arm/vein so it should have retracted easily as they normally do.They had to pull the entire needle out of the catheter in order for it to retract.No other information was provided.

• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19072132
• Report Number: 3006260740-2024-01587
• Device Sequence Number: 4732626
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/23/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REHV1902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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