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

Model Number	328000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device is unknown.No information has been provided to date.No product sample was received; therefore, visual and functional testing could not be performed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No investigation or root cause analysis could be conducted given that no complaint sample was returned.This remediation mdr was generated under protocol(b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the iv catheters were puncturing the vein above insertion site causing the veins to blow despite blood return.No patient injury was reported.

• Brand Name: JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15360412
• Report Number: 3012307300-2022-17816
• Device Sequence Number: 12062971
• Product Code: FOZ
• UDI-Device Identifier: 10351688081964
• UDI-Public: 10351688081964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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
• Device Expiration Date: 10/02/2021
• Device Model Number: 328000
• Device Catalogue Number: 328000
• Device Lot Number: 3881653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown