MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER

Model Number 326010

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Event Description

Information received a smiths medical peripheral intravenous catheters (pivc)|jelco safety viavalve catheters three different catheters of iv appear to be very blunt and was difficult penetrating the skin.

• Brand Name: JELCO
• Type of Device: CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 12374314
• MDR Text Key: 268361853
• Report Number: 3012307300-2021-08882
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: 15019517078398
• Combination Product (y/n): N
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/07/2023
• Device Model Number: 326010
• Device Catalogue Number: 326010
• Device Lot Number: 4130676
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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