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

Catalog Number	CL2000S-RC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One new list# cl2000s-rc, chemolock¿ w/red cap (lot# 5131546) and three new list# cl2100, chemolock¿ ports (lot# 5054143) were provided and visually inspected.As received, no visible damage or anomalies were identified.No used product was returned.Dry disconnect testing was performed on all four chemolock samples using red dyed water.All chemolock samples met the testing expectations outlined in the product performance specification.Although red water can be seen within the fluid path of the chemolocks, no fluid droplets were noted on the disconnected devices.The reported complaint could not be replicated or confirmed.A device history review (dhr) lot# 5168244 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event involved a chemolock® w/red cap that the customer reported the nurse had just finished her intravenous (iv) push of adriamycin and upon disconnecting she observed a drop of red on cl2100.The nurse used the alcohol swab to wipe the drop off and discarded the device.The device replaced with another without an issue.There was no report of harm.

• Brand Name: CHEMOLOCK W/RED CAP
• 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
• MDR Report Key: 11793863
• Report Number: 9617594-2021-00150
• Device Sequence Number: 19087881
• Product Code: ONB
• UDI-Device Identifier: 00887709091887
• UDI-Public: (01)00887709091887(17)260101(10)5168244
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 01/01/2026
• Device Catalogue Number: CL2000S-RC
• Device Lot Number: 5168244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1