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

Model Number	306001
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical jelco protectiv safety i.V.Catheter was inserted into a patient on (b)(6) 2019.Upon removal of the iv dressing, it was immediately noted that only the blue plastic hub of the iv device was attached to the iv extension and the iv catheter was not attached to the hub.A tourniquet was immediately placed on the patient's upper arm.X-ray images and ultrasonography revealed that the one inch catheter was still in the patient's right forearm.Subsequently, the patient had to undergo a surgical procedure for removal of the catheter.No additional adverse patient effects were reported.

• Brand Name: JELCO PROTECTIV SAFETY I.V. CATHETER
• Common Device Name: 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: 8446737
• Report Number: 3012307300-2019-01525
• Device Sequence Number: 19098395
• Product Code: FOZ
• UDI-Device Identifier: 10351688071170
• UDI-Public: 10351688071170
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 12/18/2021
• Device Model Number: 306001
• Device Catalogue Number: 306001
• Device Lot Number: 3738981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention