MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 I; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	126640489
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e, additional contact: (b)(6).
Event or Problem Description
The reported complaint involved a primary set, piggyback with backcheck valve, 3 clave y-sites, secure lock, 100 inch.It was reported that the backcheck valve did not work and it allowed unspecified medication to go up to the bag, rather than to the patient.This happened after the backcheck value was changed to the dark blue and clear.There was no human harm reported.
Additional Manufacturer Narrative
One used primary set was received for inspection/complaint investigation.The drip chamber spike was cut off from the set and not returned.The missing drip chamber spike was unrelated to the reported complaint.The set was tested for back flow per product specifications.The back check valve functioned according to product specifications with no backflow observed.The reported complaint of backflow was unable to be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 14sep2023.

• Brand Name: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 3 CLAVE Y-SITES, SECURE LOCK, 100 I
• 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: 17699673
• Report Number: 9615050-2023-00401
• Device Sequence Number: 20491279
• Product Code: FPA
• UDI-Device Identifier: 10887787005964
• UDI-Public: (01)10887787005964(17)260201(10)13513895
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 02/01/2026
• Device Catalogue Number: 126640489
• Device Lot Number: 13513895
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: UNSPECIFIED MEDICATION INFUSION BAG, MFR UNK.
• Patient Sex: Unknown