MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO IV CATHETER

Model Number	CI+2225-2C
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a spay procedure of a dog, the clinic technician had a hard time placing the iv catheter inside the vein.When the catheter was pulled out of the dog's skin, it became stuck.When the technician pulled out the catheter, about 5mm of the catheter tip broke off and remained in the dog's skin.The broken piece had to be surgically removed.Per the clinic staff, the dog is doing well.No further information was provided.
Additional Manufacturer Narrative
Manufacturer investigation report - (b)(4).
Event or Problem Description
During a spay procedure of a dog, the clinic technician had a hard time placing the iv catheter inside the vein.When the catheter was pulled out of the dog's skin, it became stuck.When the technician pulled out the catheter, about 5mm of the catheter tip broke off and remained in the dog's skin.The broken piece had to be surgically removed.Per the clinic staff, the dog is doing well.No further information was provided.

• Brand Name: NIPRO IV CATHETER
• Common Device Name: IV CATHETER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 9369650
• Report Number: 9610987-2019-00011
• Device Sequence Number: 16860582
• Product Code: FOZ
• UDI-Device Identifier: 00383790006408
• UDI-Public: 00383790006408
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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 Expiration Date: 11/30/2023
• Device Model Number: CI+2225-2C
• Device Lot Number: 18L06C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: Required Intervention