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

Model Number CI+2225-2C

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2019

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Manufacturer investigation report - (b)(4).

Event 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
• Type of Device: IV CATHETER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer (Section G): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 9369650
• MDR Text Key: 178733622
• Report Number: 9610987-2019-00011
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00383790006408
• UDI-Public: 00383790006408
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2018
• 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): Required Intervention