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

Model Number	384902
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
We have been using the intracath 22g x 8'' catheter/needle unit with wire stylet (19ga x 2'' needle).We use these routinely and many patients (dogs and cats) have these placed during hospitalization.Our technical staff is very familiar placing them.We have had 3 of these catheters in the past few months break off while in patients.It seems they are being placed using proper technique, and are not being removed with excessive force.Most recently, we had a cat with one in which half of the catheter broke off and a large piece traveled to the heart requiring referral for removal.
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.

• Brand Name: INTRACATH 22GA X 8" I.V. (19GA X 2" NEEDLE)
• Common Device Name: INTRACATH
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 13043163
• Report Number: 0001625425-2021-01232
• Device Sequence Number: 17121734
• Product Code: FOZ
• UDI-Device Identifier: 00886333210121
• UDI-Public: 00886333210121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K821372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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 Catalogue Number: 384902
• Device Lot Number: 11388796
• 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: 12/07/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown