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

Model Number	338300
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the month ((b)(6)) and year (2020) of the aware date are known.
Event or Problem Description
It was reported that the neonatal intensive care unit (nicu) nurse was unable to place the catheter on the premature infant.No ontward patient effects were reported.An i.V catheter from an alternative vendor was used on the patient.

• Brand Name: JELCO SAFETY ACUVANCE CATHETERS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 10951222
• Report Number: 3012307300-2020-12140
• Device Sequence Number: 3150021
• Product Code: FOZ
• UDI-Device Identifier: 10351688071569
• UDI-Public: 10351688071569
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K002768
• 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): 12/04/2020

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: 07/06/2023
• Device Model Number: 338300
• Device Catalogue Number: 338300
• Device Lot Number: 4023666
• 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: 11/05/2020
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR