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	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.
Event or Problem Description
The device involved a primary plumset, pe lined tubing, 107 inch where the customer reported a chemo drug leaked from filter vent during infusion.There was patient involvement and unknown patient harm.
Additional Manufacturer Narrative
The complaint of chemo drug leaking from the filter vent could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed, and rework documentation was found on a convertible piercing pin assembly with non-dehp sight chamber and filter vent cap (for 0.138 o.D.Tubing) for lot# 9551776.The latest rework was noted to be inspecting for leaks at 200%.The amount of nonconforming product did not meet the nc trigger requirement.Based on this without the return of the set the relevance of the found reworks to this complaint cannot be determined.

• 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: 18773397
• Report Number: 9615050-2024-00173
• Device Sequence Number: 17258765
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)251101(10)11352758
• 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): 04/05/2024

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: 11/01/2025
• Device Catalogue Number: 142480489
• Device Lot Number: 11352758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: UNSPECIFIED CHEMO DRUG, MFR UNK.
• Patient Sex: Unknown