MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO SAFELET CATHETER; IV CATHETER

Model Number	CI+2025-2C
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation report attached is on device history record and retained samples only.Still pending return of samples for investigation.
Event or Problem Description
Iv catheter was placed during a routine canine ovariohysterectomy that started at 8:47am on monday (b)(6) 2025.The iv catheter would have been placed a few minutes before surgery.Surgery ended at 9am, the iv catheter was removed at approximately 9:05 am and immediately the recovery tech noticed the iv catheter was not intact.The doctor went back into surgery at 9:10 am to try and remove it.Catheter had less than an hour inserted in the vein.The catheter was not successfully removed.Only the hub, the polypropylene section migrated.This is the first time this type of incident occurred.The patient is stable; the cardiologist was unsuccessful in removing the catheter from a distal pulmonary artery where it settled.Additional information received from the chief veterinary medical officer stating; the patient is stable, and there have been no secondary comorbidities linked to the issue.They are waiting for an update regarding timing of the removal.An adverse event report was submitted to health canada by the chief veterinary medical officer and he stated that it was indicated in the report that this was likely due to user error and that there was no evidence to suggest device failure.
Additional Manufacturer Narrative
Initial investigation report attached is on device history record and retained samples only.Still pending return of samples for investigation.
Event or Problem Description
Iv catheter was placed during a routine canine ovariohysterectomy that started at 8:47am on monday (b)(6) 2025.The iv catheter would have been placed a few minutes before surgery.Surgery ended at 9am, the iv catheter was removed at approximately 9:05 am and immediately the recovery tech noticed the iv catheter was not intact.The doctor went back into surgery at 9:10 am to try and remove it.Catheter had less than an hour inserted in the vein.The catheter was not successfully removed.Only the hub, the polypropylene section migrated.This is the first time this type of incident occurred.The patient is stable; the cardiologist was unsuccessful in removing the catheter from a distal pulmonary artery where it settled.Additional information received from the chief veterinary medical officer stating; the patient is stable, and there have been no secondary comorbidities linked to the issue.They are waiting for an update regarding timing of the removal.An adverse event report was submitted to health canada by the chief veterinary medical officer and he stated that it was indicated in the report that this was likely due to user error and that there was no evidence to suggest device failure.

• Brand Name: NIPRO SAFELET CATHETER
• Common Device Name: IV CATHETER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi; niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• Manufacturer (Section G): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi; niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 22151178
• Report Number: 9610987-2025-00012
• Device Sequence Number: 12715699
• Product Code: FOZ
• UDI-Device Identifier: 10383790006368
• UDI-Public: 10383790006368
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: CI+2025-2C
• Device Lot Number: 23G11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown