MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET, 15 MICRON FILTER IN SIGHT CHAMBER, SECURE LOCK, 86 CM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	14229
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4.It was reported that the material number is 14229, but this is an incomplete number.Similar device is sold under model 142290488.This product was used for the di, product code, and 501k.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
A complaint was received regarding a secondary set, 15 micron filter in sight chamber, secure lock, 86 cm that experienced leakage during use.The reporter stated that "rn spiked blood tubing into bag of blood.Rn hung blood on iv tubing.Tubing came out if bag of blood hung on pole and spilt all over patient room and rn.Charge rn informed.Md informed.Blood bank informed and new blood sent.Blood tubing supplies and blood bag given to manager.Evs informed and assisted rn in cleaning of patient room." the status of the product at the time of the event was during use on patient.The event date was on 28-apr-2025 19:08.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
Investigation summary no 14229-01 product samples, videos or photographs were returned for investigation.The dhr was not reviewed, no lot number information was provided.The complaint cannot be confirmed, without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The dhr was not reviewed, no lot number information was provided.

• Brand Name: SECONDARY SET, 15 MICRON FILTER IN SIGHT CHAMBER, SECURE LOCK, 86 CM
• 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: 22107583
• Report Number: 9615050-2025-00266
• Device Sequence Number: 12581722
• Product Code: FPA
• UDI-Device Identifier: 10887787006282
• UDI-Public: 10887787006282
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Catalogue Number: 14229
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 IV BLOOD BAG, MFR UNKNOWN.
• Patient Sex: Unknown