MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, PE LINED TUBING, 107 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142480489
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for investigation.Investigation is pending.E1 initial reporter phone number: ext.(b)(6).
Event or Problem Description
The event involved a primary plumset, pe lined tubing, 107 inch where it was reported there was leakage on tubing.The event was noted during infusion of an unknown solution.There was no unprotected drug exposure to patient or healthcare provider.There was no other physical defect noted.There was patient involvement, no patient harm and no healthcare provider harm.
Additional Manufacturer Narrative
Received an image provided by the customer showing a pink rectangle outlining red markers on the tube portion of the set.Received one used.List #142480489, primary plumset, pe lined tubing, 107 inch; lot #13518329.The complaint of leakage on the used 142480489 primary plum set can be confirmed.The image provided by the customer shows damage found between two orange marks on the tube of the plumb set.The set was leak tested per specifications.There was a leak observed from a puncture observed between two orange markers found in the exiting flow tubing after the cassette.The probable cause of the observed leakage is due to the puncture in the tubing.The cause of the damage is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUMSET, PE LINED TUBING, 107 INCH
• 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: 18317501
• Report Number: 9615050-2023-00774
• Device Sequence Number: 6115551
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)260401(10)13518329
• 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): 02/14/2024

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: 04/01/2026
• Device Catalogue Number: 142480489
• Device Lot Number: 13518329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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 SOLUTION, UNK MFR.
• Patient Sex: Unknown