MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number	338300
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle would not separate from the catheter.No adverse patient effects were reported.

• Brand Name: JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 11341542
• Report Number: 3012307300-2021-01320
• Device Sequence Number: 17383441
• Product Code: FOZ
• UDI-Device Identifier: 10351688071569
• UDI-Public: 10351688071569
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 08/28/2023
• Device Model Number: 338300
• Device Catalogue Number: 338300
• Device Lot Number: 4046981
• 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: 01/18/2021
• Initial Report FDA Received Date: 02/18/2021
• 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