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

Catalog Number	3357
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon discontinuing an iv placed in the left antecubital site, a peripheral intravascular catheter became detached from the hub when attempting to remove the device and the catheter remained in the patient.The detached catheter required medical intervention but no patient injury was associated with this incidence.
Additional Manufacturer Narrative
Additional information was received indicating that two days following the hub detachment with in the patient medical intervention was provided.The patient underwent conscious sedation with local anesthesia to remove the radiopaque thrombus to the left cephalic vein.Repeat imaging was performed to confirm that the foreign body in whole of was removed.No further adverse effects were reported.

• Brand Name: JELCO® ACUVANCE® 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: 7531812
• Report Number: 3012307300-2018-01750
• Device Sequence Number: 945485
• Product Code: FOZ
• UDI-Device Identifier: 10351688071453
• UDI-Public: 10351688071453
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K012128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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: Nurse
• Device Catalogue Number: 3357
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/18/2018
• 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
• Patient Age: 56 YR
• Patient Weight: 91