MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿, 5 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL2000S-5
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a chemolock¿, 5 units.The report stated that chemolock and chemolock port easily disconnects.There were three instances when it happened: (1) cstd got easily disconnected with minimal force with different bd sets.The set locks and spins but disconnects.(2) cl2100 & cl2000s easily disconnects with minimal touching of wings.(3) the disconnects were also demonstrated at a meeting.This report reflects 3 same/similar incidents of the same complaint issue/failure mode with the same lot number.
Additional Manufacturer Narrative
The complaint of disconnection on item no.Cl2000s-5 cannot be confirmed.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 probable cause cannot be determined.The device history record was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: CHEMOLOCK¿, 5 UNITS
• 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: 19386114
• Report Number: 9617594-2024-00645
• Device Sequence Number: 11780059
• Product Code: ONB
• UDI-Device Identifier: 00887709071728
• UDI-Public: (01)00887709071728(17)281201(10)13847936
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: CL2000S-5
• Device Lot Number: 13847936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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: CHEMOLOCK PORT LIST CL2100 LOT UNK, MFR ICUMEDICAL.; UNSPECIFIED EXTENSION SET, MFR BD.
• Patient Sex: Unknown