MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿, 10 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL2000S-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a chemolock port, where a medwatch report was filed.The reporter who elected to not be identified stated device broke, spilling hazardous chemotherapy medication with employee exposure.There was no patient involvement, however the customer stated an unspecified harm due to hazardous chemotherapy medication with employee exposure.
Additional Manufacturer Narrative
The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.User facility/importer report number mdr report number: mw5110951.
Additional Manufacturer Narrative
No product samples, videos, or photographs were provided for investigation.The device history record (dhr) was reviewed and there was a non-conforming material report that describes a "separation at the junction of the components blue body and collar".This coincides with the described complaint and as such the complaint is confirmed based on the defect found of an insufficient ultrasonic weld during assembly.The probable cause of the breakage is insufficient energy director melt and penetration during ultrasonic welding.

• Brand Name: CHEMOLOCK¿, 10 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15250263
• Report Number: 9617594-2022-00240
• Device Sequence Number: 5682069
• Product Code: ONB
• UDI-Device Identifier: 00887709071735
• UDI-Public: (01)00887709071735(17)261001(10)5604904
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 10/01/2026
• Device Model Number: CL2000S-10
• Device Catalogue Number: CL2000S-10
• Device Lot Number: 5604904
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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: UNSPECIFIED CHEMOTHERAPY, UNK MFR.
• Patient Sex: Unknown