MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC9013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer, where it was reported the oncology unit reported an incident with leaking filter, which resulted in a missed dose portion in the treatment of chemotherapy.The infusion was a mix of doxorubicin, vincristine, etoposide.There were multiple orange (color of chemo) spots found on sheet & pique, discovered in the morning of october 18, filter looked wet and leaking, tubing itself and connections not leaking.The quantity remaining in the bag and tubing (about 7% of the dose) was not administered.The tubing was discarded.An update from the customer on (b)(6) 2024 stated that they have removed all filters with lot#: 13893262 from the hematology-oncology unit.The set up was: mc9013 was added to the usual primary tubing (bbraun 363430)- their ¿chemo line¿.The end of mc9013 was attached to the lowest y port on the usual primary tubing (bbraun 363430) - their ¿mainline¿ for hydration.No hole, cut, tears or any defect noted.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.E1: initial reporter phone number: (b)(6).Plots: 13893262, manufacturing date: 2/1/2024, expiration date: 2/1/2029.14093636, manufacturing date: 7/1/2024, expiration date: 7/1/2029.
Additional Manufacturer Narrative
Received one (1) new mc9013 ext set w/0.2 micron filter for inspection.No defects or anomalies were noted.The set was leak-tested per product specifications.There was no leakage.The reported complaint could not be replicated or confirmed.Without the return of the used sample, a comprehensive failure investigation cannot be performed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20668192
• Report Number: 9617594-2024-01594
• Device Sequence Number: 8237431
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: 00887709039391
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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 Catalogue Number: MC9013
• Device Lot Number: PLOTS
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: MIX OF DOXORUBICIN, VINCRISTINE, ETOPOSIDE, UNK MFR.; PRIMARY TUBING (BBRAUN 363430).
• Patient Sex: Unknown