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	12/29/2023
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 complaint of a loose needle cap was confirmed.The product returned for evaluation was one 20g accucath ace.The unit was returned with the needle retracted and the cap decoupled from the needle assembly.No use residues were observed throughout the unit.The guidewire tip was observed to be inside the catheter tubing.Microscopic inspection of the components found that the catheter tip had a flared segment likely suggesting that the coils of the guidewire tip had been resting against the catheter tip for an extended period of time.Additionally, inspection of the needle cap found that the ridges which allow the cap to couple with the needle assembly were deformed.The needle cap was functionally tested by attempting to couple and decouple the needle cap with the needle assembly.The cap was able to be coupled, however, a very small amount of force was needed when decoupling the components.It is likely that the deformation seen on the needle cap was preventing a proper fit from forming with the needle assembly.However, there was not sufficient evidence to determine how the damage to the needle cap occurred.Additionally, it is unknown if the damage to the catheter tip was related to the premature retraction.H3 other text : evaluation findings in section h:11.
Event or Problem Description
It was reported by customer that, "i opened a package this morning to insert an accucath on a patient and found a defective catheter.The cap was not snapped on and the needle had been retracted." no other information was provided.(b)(6) 2024 - the returned device exhibited the needle retracted and the cap decoupled from the needle assembly.

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19351811
• Report Number: 3006260740-2024-02429
• Device Sequence Number: 7281320
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/17/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REHX0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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