MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INTRACATH 22GA X 8" I.V. CATHETER/NEEDLE (19GA X 2" NEEDLE)

Model Number	384902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Hello, we recently had an intracath failure where that catheter broke off while placed in a patient.I was wondering if you have had any defects reported with your 22g x8" intracaths (ref#384902).I would appreciate the opportunity to discuss this with a quality assurance representative.Email is the best method of contact.Additional information received indicating remaining portion migrated to the patient's lung tissue.Transferred patient to another facility.Unsure of outcome at this point.A new intracath was not placed.Lot number: 11552911 (packaging not available at time of incident but this is the only lot number we have currently in the hospital.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.According to the customer, there was no sample available for review.Additionally, there has been no visual evidence provided to support the alleged reported issue.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.There have been no other complaints found to be related to this lot number.

• Brand Name: INTRACATH 22GA X 8" I.V. CATHETER/NEEDLE (19GA X 2" NEEDLE)
• Common Device Name: INTRACATH
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19244139
• Report Number: 0001625425-2024-01012
• Device Sequence Number: 12608511
• Product Code: FOZ
• UDI-Device Identifier: 00886333210121
• UDI-Public: (01)00886333210121(17)281227(10)11552911
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K821372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 384902
• Device Lot Number: 11552911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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