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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for investigation.Investigation is pending.E1 - initial reporter phone has an extension number of (b)(6).
Event or Problem Description
The event involved a primary plumset, pe lined tubing, 107 inch where it was reported that during insulin infusion.The registered nurse (rn) went to initiate new infusion, then identified different infusion back filling with blood from femoral central venous catheter (cvc) catheter line into infusion tubing and blood leaking out onto bed.Identified a small crack in line.Unknown how long line was open, case followed by infection control for risk of central line-associated bloodstream infection.There was patient involvement but unknown patient harm.
Additional Manufacturer Narrative
The complaint of leakage on the 142480489 primary plum set can be confirmed.The set was leak tested per specifications.There was a leak observed from the cut found in the tubing just above the secure lock male adaptor.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.The probable cause of the observed leakage is due to the cut in the tubing.The cause of the damage is unknown; however, it would have occurred outside of icu medical control as it occurred after priming set up.The lot history was reviewed and 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: 18484979
• Report Number: 9615050-2024-00023
• Device Sequence Number: 2821178
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)251001(10)9405818
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: 10/01/2025
• Device Catalogue Number: 142480489
• Device Lot Number: 9405818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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: CENTRAL VENOUS CATHETER, MFR UNK; UNSPECIFIED INFUSION, MFR UNK
• Patient Sex: Unknown