MAUDE Adverse Event Report: NEO MEDICAL INC. NEOMAGIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 1943-1608

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/30/2022

Event Type  malfunction  

Event Description

The patient had an extended dwell i.V.In her arm, the mother called nurse to bedside advising the extended dwell came out.When the dressing was removed the entire catheter has still in the patient's arm.The catheter broke off the yellow hub.The catheter was easily removed and measured to make sure the entire 8 centimeters was out of the patient.A neonatal nurse practitioner was notified.The remaining pieces were given to charge nurse.It's unclear whether the product is faulty or it was tugged on when the baby was being held by the mother.Either way it's concerning that it broke off in the baby.

• Brand Name: NEOMAGIC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): NEO MEDICAL INC.; 1375 greg st ste 108; sparks NV 89431
• MDR Report Key: 15334759
• MDR Text Key: 299068794
• Report Number: 15334759
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1943-1608
• Device Catalogue Number: 1943-1608
• Device Lot Number: 1029
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Female
• Patient Weight: 3 KG