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

Model Number 326710

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical peripheral intravenous catheters (pivc)|jelco safety viavalve catheter, broke while it was being inserted by the nurse.It was also reported that the broken piece of needle stayed in the actual catheter.No adverse effects were reported.

• Brand Name: JELCO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 12474364
• MDR Text Key: 271471556
• Report Number: 3012307300-2021-09365
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078435
• UDI-Public: 15019517078435
• Combination Product (y/n): N
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/16/2021
• Device Model Number: 326710
• Device Catalogue Number: 326710
• Device Lot Number: 3868797
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1