MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ BAG SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was reported as not available for return to the manufacturer.The investigation into this incident is ongoing.As additional information is received; a supplemental report will be issued.
Event or Problem Description
It was reported that during use with a chemolock¿ bag spike a cisplatin bag leak occurred due to the spike poking a hole through a baxter port resulting in the chemotherapy coming in contact with the patient or healthcare provider.The drug was remixed and chemolock was not replaced.There was patient involvement but no harm was reported.This is report 2 of 2.
Additional Manufacturer Narrative
A representative photograph was returned that shows the spike tip of a cl-10 bag spike that has penetrated through the sidewall of the infusion bag access port.There does not appear to be any cl-10 bag spike damage or anomalies visible from the photograph returned.The device history review (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause of the complaint cannot be determined without return of the affected sample.

• Brand Name: CHEMOLOCK¿ BAG SPIKE
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13994969
• Report Number: 9617594-2022-00071
• Device Sequence Number: 17228407
• Product Code: ONB
• UDI-Device Identifier: 00887709056961
• UDI-Public: (01)00887709056961(17)260901(10)5589706
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 09/01/2026
• Device Model Number: CL-10
• Device Catalogue Number: CL-10
• Device Lot Number: 5589706
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: BAXTER PORT; CISPLATIN, MFR UNK
• Patient Sex: Unknown