MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTRAVASCULAR CATHETER (18G); 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	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "18g accucath was inserted on patient and when the clinician went to retract the needle, she pushed the button, and nothing happened.The needle did not retract.She then pulled the needle out of the catheter hub to see if that would help the needle to retract.The needle still did not retract.The white button would actively click, but the needle failed to retract.".
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a needle not retracting is confirmed but the exact cause remains unknown.Three photo samples of an accucath device were provided for evaluation.The first photo shows the distal end of the device.The needle has not been retracted by the safety and the guidewire is fully advanced.It could not be clearly determined if the safety button has been pressed.The second and third photo show the distal end of the device housing.The view of the photos does not allow for a clear view of the position of the needle.It is unknown if the needle is partially retracted or fully extending.The spring within the housing appears to be elongated on the left side but bunched on the right side.The characteristics of the components could not be clearly inspected for a determination of potential interference issues or damage.Since the bunching of the spring is visible within the housing and may contribute to a needle retraction issue, the complaint is confirmed; however, the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "18g accucath was inserted on patient and when the clinician went to retract the needle, she pushed the button, and nothing happened.The needle did not retract.She then pulled the needle out of the catheter hub to see if that would help the needle to retract.The needle still did not retract.The white button would actively click, but the needle failed to retract.".

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER (18G)
• 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: 15353179
• Report Number: 3006260740-2022-03458
• Device Sequence Number: 6002883
• Product Code: FOZ
• UDI-Device Identifier: 00801741138003
• UDI-Public: (01)00801741138003
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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 Model Number: N/A
• Device Catalogue Number: AC1182252
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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