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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

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 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 1 of 2.

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
• Type of Device: 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: 13994961
• MDR Text Key: 294657202
• Report Number: 9617594-2022-00072
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00887709056961
• UDI-Public: (01)00887709056961(17)260901(10)5589706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BAXTER PORT; CISPLATIN, MFR UNK