MAUDE Adverse Event Report: NULL JELCO PLUS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM

Model Number	328500
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: a device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.Without the defective unit, the failure investigation couldn't carry out.No testing or visual inspection could be performed, as no product was made available for evaluation.G2 unknown 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 catheter was ridged and difficult to channel.The device was unable to insert easily and the patient skin contact causing pain and burning in the vein: no medical or surgical intervention was reported.

• Brand Name: JELCO PLUS
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM
• Manufacturer (Section G): NULL
• MDR Report Key: 15360385
• Report Number: 3012307300-2022-17809
• Device Sequence Number: 5227512
• Product Code: FOZ
• UDI-Device Identifier: 10351688081933
• UDI-Public: 10351688081933
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/03/2025
• Device Model Number: 328500
• Device Catalogue Number: 328500
• Device Lot Number: 3929609
• 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: 04/21/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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