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

Catalog Number	335903
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that an ultrasound machine was used to insert a smiths medical jelco® acuvance® safety i.V.Catheter.It was reported that the clinician got a flash after insertion, could not advance the catheter, was removed with noted catheter shearing at the end of the tip.An x-ray was performed and revealed that the sheared catheter piece was in the patient's vein.Subsequently, the catheter tip was surgically removed.Information was noted that upon threading the catheter from the stylet, a blunt metal piece was extracted from the bevel of the needle, and redirecting the catheter makes it easier to shear the catheter.There was no reported adverse effects.

• Brand Name: JELCO® ACUVANCE® SAFETY I.V. CATHETERS
• 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: 7282599
• Report Number: 3012307300-2018-00324
• Device Sequence Number: 16173739
• Product Code: FOZ
• UDI-Device Identifier: 10351688071439
• UDI-Public: 10351688071439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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: No Information
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: 335903
• Device Lot Number: 3386537
• 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: 01/22/2018
• Initial Report FDA Received Date: 02/20/2018
• 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