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

Model Number	335603
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
While catheter was into patient's vein, the user could not easily remove the mandrel from the catheter which led to pain and wound for patient.Issue occurred *frequently during the last few months.
Additional Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device, the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed, that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 11341521
• Report Number: 3012307300-2021-01318
• Device Sequence Number: 17383439
• Product Code: FOZ
• UDI-Device Identifier: 10351688071446
• UDI-Public: 10351688071446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2021

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: 03/13/2023
• Device Model Number: 335603
• Device Catalogue Number: 335603
• Device Lot Number: 3953044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1