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

Catalog Number	308500
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical jelco® protectiv® safety i.V.Catheter did not have a sharp retract; sharp did not retract as no movement occured.There were no reported adverse effects.

• Brand Name: JELCO® PROTECTIV® 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: 7527385
• Report Number: 3012307300-2018-01627
• Device Sequence Number: 1438604
• Product Code: FOZ
• UDI-Device Identifier: 10351688071309
• UDI-Public: 10351688071309
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Paramedic
• Device Expiration Date: 02/18/2020
• Device Catalogue Number: 308500
• 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: 04/25/2018
• Initial Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1