MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK¿ PORT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CL2100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a chemolock¿ port that experienced leakage.The report stated that the chemolock port luer lock end became separated from primary line spilling moderate amount of cytotoxic, hd1 material onto a staff member and floor.There was unknown patient involvement and unknown patient harm.The tubing that was collected is only the chemolock components.A hazardous chemotherapy agent was infused through the tubing.The drug was called cyclophosphamide and is a group 1 hazardous drug.A sample photo was provided showing the defective device.
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.Investigation summary one photo was shared by the customer, where the chemolock port is observed inside a plastic bag, no damage, leak or anomalies are observed on the photos.One (1) used list# cl2100, chemolock¿ port connected to an unknown, extension with drip chamber, 2 chemo lock were returned for evaluation.As received no physical damage or anomalies were observed.No mating device was returned for evaluation (primary line).The returned sample was tested as per procedure and no leaks or anomalies were confirmed.The male luer were complied with iso design expectations.A dhr lot# review could not be conducted because no lot number(s) was/were identified.Without the return of the mating device, the reported complaint of leaks cannot be confirmed or replicated.

• Brand Name: CHEMOLOCK¿ PORT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20767017
• Report Number: 9617594-2024-01674
• Device Sequence Number: 15769118
• Product Code: FPA
• UDI-Device Identifier: 00887709057005
• UDI-Public: 00887709057005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2024

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: CL2100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown