MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SERIVA CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	328600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that with the device, prior to the needle protracting into the safety cage, blood began leaking out and continued to leak until the saline lock was attached.Because it was so unusual for all the leaking they inspected the hub of the catheter in situ, and noted the pink plastic cathlon was broken off at the hub, exposing the steel insert inside.There was patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
Two used devices were returned for evaluation.Visually evaluated for potential nonconformances.Both samples displayed evidence of proper actuator-to-tube securement.Leak testing, using a water-filled syringe, was completed on both samples.Neither of the samples displayed catheter leakage of the catheter tubing consistent with the complaint.The customer's issue could not be confirmed.The root cause could not be determined.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: JELCO SERIVA CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19596593
• Report Number: 1219611-2024-00016
• Device Sequence Number: 8525034
• Product Code: FOZ
• UDI-Device Identifier: 10351688081957
• UDI-Public: (01)10351688081957(17)251117(10)4444200
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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: 11/17/2025
• Device Catalogue Number: 328600
• Device Lot Number: 4444200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• 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