MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX OPTIVA WINGED IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 1122-AI

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: g5: 510k is blank, this catalog number is not sold in the united states.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The product's history records were reviewed, no service-related issues that would have resulted in the reported complaint were identified.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that a cat with an unknown condition with no known concomitant medical condition had the catheter placed by the attending veterinarian.On removal the tube ruptured, and a part of the catheter remained in the vein of the cat.They internally coded this as a foreign body not "gi".A piece of the tubing stuck in the vein and the veterinarian was able to grasp it and remove the entire tubing.An new catheter was placed on a cat to rehydrate it without any issue.The cat's vein was not injured.About thirty catheters from the box have been used, to date, only one has a quality defect.

• Brand Name: PORTEX OPTIVA WINGED IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18112392
• MDR Text Key: 328777033
• Report Number: 3012307300-2023-10443
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 1122-AI
• Device Lot Number: 4310857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1