MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 4 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	121959290
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a primary plum set, 4 clave multiport connector, ball check valve in sight chamber, 15 micron filter, clave secondary port, clave y-site, polyethylene lined light resistant tubing, secure lock, 216 cm.A leak was reported on the rinsing line of the 4v shaft during patient use (at the day hospital the previous friday).They did not know which lot was affected; however, there were four lots in stock in the department: 14104140, 14076833, 13969330, 14104142.There was no blood loss considered clinically significant.5% glucose was used for rinsing.There was no exposure to the healthcare professional and the leak did not come into contact with the patient.The leak was cleaned up according to the facility's protocol with no specific kit.The patient received the full intended dose.There was no delay in therapy, no adverse clinical consequences and nobody was injured.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The following items were provided by the customer for investigation: -one used list #121959290, primary plum set, 4 clave multiport connector, ball check valve in sight chamber, 15 micron filter, clave secondary port, clave y-site, polyethylene lined light resistant tubing, secure lock, 216 cm; lot #unknown ---> one used list #unknown extension set w/ orange tubing; lot #unknown.---> three used list #unknown, extension set; lot #unknown ---> one used.List #unknown, 5% glucose 100ml bottle; lot #15tmb780.---> one used list #unknown, 0.9% sodium chloride 100ml bottle; lot #15uba010.---> two used list #unknown, 5% glucose 200ml bag; lot #14tk7113.---> one used list #unknown, 0.9% sodium chloride 50ml bag; lot #17tms091.A tear was observed on the tubing near the back spike of the used device.The reported complaint of a leak could be confirmed.The returned sample leaked near the bag spike.A tear was observed on the tubing at the location of the leak.The probable cause is from an unintentional pulling force during use.D9 - date returned to mfg: 28apr2025.This supplemental emdr report contains an improved b5 description.
Event or Problem Description
The event involved a primary plum set, 4 clave multiport connector, ball check valve in sight chamber, 15 micron filter, clave secondary port, clave y-site, polyethylene lined light resistant tubing, secure lock, 216 cm.A leak of 5% glucose on the 4v rinsing shaft was reported during use on a patient.There were no adverse clinical consequences and nobody was injured.There was no delay in therapy and this one was completed.There was no blood loss considered clinically significant.The patient received the full intended dose.

• Brand Name: PRIMARY PLUM SET, 4 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER
• 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: 21877721
• Report Number: 9615050-2025-00190
• Device Sequence Number: 7899855
• Product Code: FPA
• UDI-Device Identifier: 00887709102460
• UDI-Public: 00887709102460
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2025

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: 121959290
• Device Lot Number: UNKNOWN
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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: 5% GLUCOSE RINSE, MFR UNK.; UNSPECIFIED INFUSATE, MFR UNK.
• Patient Sex: Unknown