MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	14220-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - this complaint was received through: (b)(6).Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with regards to a primary plum y-type blood set, 200 micron filter, clave secondary port, clave y-site, non-vented, secure lock, 110 inch experienced leakage.The reporter stated, ¿leaks from drip chamber." the event occurred during infusion.It was also mentioned that there was concomitant drug, no concomitant device, no bleed-back, no chemo, no bio-hazard and unknown user facility med-watch.Tquantity affected is 1 and it is available for return for evaluation.Sample photo was provided showing the leaks from the drip chamber.There was patient involvement, no adverse event/patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
A picture was returned showing blood leaking from the base of the blood filter.Received one used list #14220-01 primary plum y-type blood set for complaint investigation.As received, uv light inspection showed inconsistent solvent application was observed at the base of the blood filter drip chamber.No additional damages or anomalies were observed.The set was air pressure leak tested per specification.No leakage was observed.In attempts to replicate clinical use, the set was primed per packaging directions.During priming, a leak was observed from the base of the blood filter drip chamber when it was squeezed.The complaint of leakage from the drip chamber can be confirmed.The probable cause is due to inconsistent solvent application during the manufacturing assembly process.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-
• 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: 20764614
• Report Number: 9615050-2024-00854
• Device Sequence Number: 18289544
• Product Code: FPA
• UDI-Device Identifier: 10887787002475
• UDI-Public: (01)10887787002475(17)260201(10)13514414
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• 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): 01/16/2025

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: 14220-01
• Device Lot Number: 13514414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Patient Sex: Unknown