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	306601
Medical Device Problem Codes	Device Alarm System (1012); Difficult to Advance (2920)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that while a smiths medical catheter was in use, device was difficult to thread.No patient injury resulted.
Additional Manufacturer Narrative
Device evaluation: one smiths medical cadd legacy pump was returned for analysis in a good condition.During analysis, the reported problem could not be duplicated.Evidence in the log suggested that a possible low battery condition which was also supported by lec 1310.Service will perform preventive maintenance to correct the reported problem.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event is unknown.

• 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: 8494216
• Report Number: 3012307300-2019-01876
• Device Sequence Number: 13879159
• Product Code: FOZ
• UDI-Device Identifier: 10351688071170
• UDI-Public: 10351688071170
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 05/30/2019

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: No Information
• Device Expiration Date: 11/06/2021
• Device Catalogue Number: 306601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1