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

Model Number 3060

Device Problem Kinked (1339)

Patient Problem Hematoma (1884)

Event Date 04/04/2018

Event Type  malfunction  

Event Description

When putting an iv on this patient, the iv catheter kinked and the patient had a big hematoma.Rn did it the second time and it happened.According to another nurse it also happened twice the day before.Reported to clinical manager.

• Brand Name: PROTECTIV
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD. INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7493796
• MDR Text Key: 107587203
• Report Number: 7493796
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/19/2020
• Device Model Number: 3060
• Device Lot Number: 3548193
• Other Device ID Number: GTIN 1035188071187
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR