MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿, 20 DROP IN-LINE DRIP CHAMBER,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	011-CL3020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 40" (102 cm) appx 4.9 ml, admin set w/chemolock¿, 20 drop in-line drip chamber, spiros®, bag hanger.A split in the line that was easily visible was reported while a patient was getting an infusion of an unspecified monoclonal antibody.As a result, a light mist sprayed onto the patient's face.The patient did not complain.A small mist went onto the nurse's clothing.Although there was a delay in the patient's therapy, there was no harm to either the patient or the nurse as a result of this complaint/event.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Received one (1) used.List #011-cl3020, 40" (102 cm) appx 4.9 ml, admin set w/chemolock¿, 20 drop in-line drip chamber, spiros®, bag hanger; lot #13659757, confirmed customer complaint of split tubing, leak.Probable cause due to unintentional pulling force during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 12jun2024.Corrected information can be found in d4.D4, g4: model number is not sold in the us but similar device is sold under model cl3020.List number cl3020 was used for the di and 501k.

• Brand Name: 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿, 20 DROP IN-LINE DRIP CHAMBER,
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19414873
• Report Number: 9617594-2024-00683
• Device Sequence Number: 15640117
• Product Code: FPA
• UDI-Device Identifier: 00887709072923
• UDI-Public: 00887709072923
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 011-CL3020
• Device Lot Number: 13659757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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 MONOCLONAL ANTIBODY, MFR UNK.
• Patient Sex: Unknown