MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142540489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that on an unknown date a primary plum set, clave secondary port, 2 clave y-sites, 0.2 micron filter, secure lock, 112 inch sets are leaking in high frequency in the chemo suites during patient use.The medication involved was paclitaxel.There were two drops on the patient, drops were absorbed onto a blue pad, the patient's skin was cleansed, and instructions were provided for laundering clothing.The chemo drug came into contact with clothing.There was unprotected chemodrug exposure to the patient.The chemo drug spill was cleaned up per facility protocol.There were no holes, cuts, tears, or any defects noted.The affected sample was attached to a tubing set with a closed system transfer device - chemolock.It was also stated that the chemo was coming out of the two circles on the back of the filter case.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
An image of the inline filter of the primary plum set was provided by the customer.Received one (1) used list #142540489 primary plum set connected to a chemolock connector.There was no damage or anomalies noted on the set either set.The returned sample was leak-tested per product specifications.There were no leaks observed.The complaint of leakage cannot be confirmed on the returned used sample.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 1/29/2024.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, 2 CLAVE Y-SITES, 0.2 MICRON FILTER, SECU
• 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: 18390052
• Report Number: 9615050-2023-00812
• Device Sequence Number: 3967519
• Product Code: FPA
• UDI-Device Identifier: 10887787006039
• UDI-Public: (01)10887787006039(17)260701(10)13684576
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/07/2024

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: 07/01/2026
• Device Catalogue Number: 142540489
• Device Lot Number: 13684576
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 12/24/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: PACLITAXEL, UNK, MFR.
• Patient Sex: Unknown