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

Catalog Number	306701
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that when patient was on an iv the catheter was leaking under the skin at the hub.She was forced to remove this iv and start another one.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.The sample was visually examined for potential nonconformances.The device displayed no flash in the flashback chamber with no cannula or catheter bevel tip irregularities or damage to the porous barrier & sheath components noted.Visual examination of the needle guard assembly displayed no evidence of voids in the fipg adhesive chamber.Visual examination of the catheter assembly displayed no evidence of cracked catheter hub, catheter hub luer damage, eyelet-to-tube securement issues or punctured catheter tube.Pressure testing of the catheter assembly using a water filled syringe to simulate leakage testing indicated no evidence of leakage.Based on the device analysis, the complaint cannot be confirmed as a manufacturing-related nonconformance.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.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Icu medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.

• Brand Name: JELCO INTRAVASCULAR THERAPEUTIC 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19967606
• Report Number: 1219611-2024-00034
• Device Sequence Number: 21074441
• Product Code: FOZ
• UDI-Device Identifier: 10351688071217
• UDI-Public: (01)10351688071217(17)260523(10)4399690
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 05/23/2026
• Device Catalogue Number: 306701
• Device Lot Number: 4399690
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 51 KG
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native