MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/CHEMOLOCK¿ W/RED CAP, CHEMOLOCK¿ PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL4136
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.
Event or Problem Description
A medsun medwatch mandatory report uf/importer report # (b)(4) was received.The incident involved an oncology kit with chemolock with red cap.Per the report, the chemolock port malfunctioned.The nurse put the 'male' piece on y-port of saline line to give 5-fluorouracil (fu) chemotherapy.The nurse was able to flush and get blood return for the first 2-3mls of the 5-fu push then met resistance and unable to get blood return.The connections were checked and no issues noted but still not working.The nurse changed the 'male' piece of chemolock port and was able to flush/get blood return.There was patient involvement but no report of patient harm.
Additional Manufacturer Narrative
The complaint of no flow/ can't prime/ difficult to prime on item cl4136 cannot be confirmed by investigation since 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 probable cause cannot be determined.The lot history was reviewed and no non conformities were found that would have led the reported condition on the complaint.
Event or Problem Description
The customer contacted the manufacturer on 09-nov-2023 and stated that no additional information was available regarding the incident and the sample was not available for evaluation.

• Brand Name: ONCOLOGY KIT W/CHEMOLOCK¿ W/RED CAP, CHEMOLOCK¿ PORT
• 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: 18100348
• Report Number: 9617594-2023-00957
• Device Sequence Number: 20762663
• Product Code: ONB
• UDI-Device Identifier: 00887709096134
• UDI-Public: (01)00887709096134(17)270901(10)8983871
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: CL4136
• Device Lot Number: 8983871
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/22/2023
• 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: 5-FU, MFR UNK.
• Patient Sex: Unknown