MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. INTRACATH 19GA 12IN; INTRAVENOUS CATHETER

Catalog Number 384904

Device Problem Failure to Advance (2524)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/18/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The product is not available to be returned for evaluation.A review of the device history records and inspection records was conducted, and no similar concerns were found.Without the return of the sample, a root cause for the complaint occurrence could not be determined with confidence.Per the risk management documentation, potential causes include product shifting during shipping and handling and manipulation of the assembly in the user environment (i.E.Catheter withdrawn through needle).Without the return of the product, the product complaint could not be confirmed.

Event Description

Please note that this is a veterinarian patient.Catheter was being placed in patient's right medial saphenous vein.The catheter was not inside the needle and could not be fed back into the needle.Patient lost approximately 25ml of blood.

• Brand Name: INTRACATH 19GA 12IN
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5995466
• MDR Text Key: 56332513
• Report Number: 1625425-2016-00060
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K821372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 384904
• Device Lot Number: 11136795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other