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

Model Number	3057
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Rn was starting an iv on this pt in the left forearm using a 20 gauge proctiv angio catheter.After inserting the catheter, the rn was activating the sharp safety mechanism to remove the needle and heard no click and the needle kept coming and the pink hub just fell to the ground.The white teflon piece was missing.Examined to pink hub and it appears the white teflon piece was there but was torn away.The pt's arm was examined, could not feel any hard areas.The pt's arm was xrayed from finger tips to collar bone, nothing was detected.The situation was explained to the pt and family member by the physician and rn.The pt was sent to the emergency room via ambulance for further studies / ct scan / mri to attempt to locate the device.Fda safety report id# (b)(4).

• Brand Name: JELCO PROCTIV SAFETY IV CATHETER RADIOPAQUE
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; southington CT 06489
• MDR Report Key: 8960469
• Report Number: MW5089528
• Device Sequence Number: 16682112
• Product Code: FOZ
• UDI-Device Identifier: 10351688071149
• UDI-Public: 10351688071149
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2020
• Device Model Number: 3057
• Device Lot Number: 3773651
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 78 YR