MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. MICROBORE EXTENSION SET - 7 INCH, SPIN COLLAR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126570480
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a microbore extension set - 7 inch, spin collar where the customer reported issues with disconnection.There was patient involvement and delay in treatment reported, however, no report of patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is still pending.
Additional Manufacturer Narrative
Received one opened/unused list #126570480 microbore extension set.Anomalies were observed in the fluid path of the female luer lock adapter.An anomaly was also observed of the post of the white cap of the female luer lock adapter.No additional damage or anomalies noted.How or when these anomalies formed cannot be determined.Inspection under ultraviolet (uv) light showed sufficient solvent on both ends of the extension set.Both the male and female sides of the set were measured, and both sides passed per specification.The complaint of disconnection cannot be confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: MICROBORE EXTENSION SET - 7 INCH, SPIN COLLAR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19115479
• Report Number: 9615050-2024-00307
• Device Sequence Number: 7102377
• Product Code: FPA
• UDI-Device Identifier: 10887787005582
• UDI-Public: (01)10887787005582(17)261001(10)13725825
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K142974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 10/01/2026
• Device Catalogue Number: 126570480
• Device Lot Number: 13725825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAVE NEUTRAL CONNECTOR B3300, ICU MEDICAL
• Patient Sex: Unknown