MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUMSET 3CLV+BKC VALV-SL V PIN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	149510488
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred regarding a set administration 19 ml secure lock where the report stated that the iv tubing levophed had pin hole found with wet sheet/pillow during morning bedside shift report.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
One used plumset 3clv+bkc valv-sl v pin was returned for evaluation and upon visual inspection, there was a tear on the tube.The tear through the tube was a straight and clean cut.The reported complaint cut tubing can be confirmed.The probable cause is due to interactions with a sharp object.The manufacturing process was reviewed and there are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.Corrected information in d8, d4(lot #, expiration date, expiration date null), h4 as the provided possible lot number does not matches with the catalogue number.Hence in d4: only di provided as lot number is unknown.

• Brand Name: PLUMSET 3CLV+BKC VALV-SL V PIN
• 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: 23417054
• Report Number: 9615050-2025-00504
• Device Sequence Number: 10408340
• Product Code: FPA
• UDI-Device Identifier: 10887787003205
• UDI-Public: 10887787003205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 149510488
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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: LEVOPHED, MFR UNKNOWN
• Patient Sex: Unknown