MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL JELCO 20 GAUGE IV CATHETER; PROTECT IV

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 04/15/2018

Event Type  Injury  

Event Description

Iv catheter became detached from hug and lodged in pt vein requiring surgical removal under anesthesia.Pt doing well post op.Pt came to hospital ed via ems (with copd and gi issues), which had started the iv.Pt was admitted and 10 hours later iv was leaking.When rn attempted to remove iv, it was discovered that only hub was visible and catheter was not attached.Unable to retrieve catheter without surgery.Unfortunately, operating room did not save retrieved catheter.

• Brand Name: SMITHS MEDICAL JELCO 20 GAUGE IV CATHETER
• Type of Device: PROTECT IV
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st. ; southington CT 06489
• MDR Report Key: 7457907
• MDR Text Key: 106702504
• Report Number: 7457907
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2018
• Event Location: Other
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 75