MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECT IV PLUS SAFETY IV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Model Number 24 GAUGE

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem Hypoglycemia (1912)

Event Date 04/13/2016

Event Type  malfunction  

Event Description

Rn was trying to start an iv on a newborn being admitted to the nicu for hypoglycemia and when the nurse removed the catheter because she couldn't get it to advance, the plastic tip was bent and almost sheared off.

• Brand Name: PROTECT IV PLUS SAFETY IV CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen street; southington CT 06489
• MDR Report Key: 5596971
• MDR Text Key: 43324763
• Report Number: 5596971
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 24 GAUGE
• Device Catalogue Number: 3063
• Device Lot Number: ST3142417
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1