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

Catalog Number	CL2100
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a port chemolock ca/50 disconnected during patient use.The report stated, "chemo lock faulty, disconnected from line and spontaneously detached." one sample is retained and is available for investigation.There was no patient harm reported.
Additional Manufacturer Narrative
One photo was shared by the customer, where the item cl2100 is observed inside a plastic bag and the blue body is observed to be detached, no additional damage or anomalies are observed.One used 0.9% sodium chloride injection usp nacl 0.9% baxter 250 ml intravenous bag connected to an unknown, bd infusion set and to one used.List #cl2100, chemolock¿ were returned for evaluation.As received the chemolock port was observed to have separated the blue body.Once both parts no welding evidence was observed.Complaint of chemolock faulty and spontaneously detached can be confirmed.The probable cause is due to inconsistences during welding process.A device history lot # review could not be conducted because no lot number(s) was/were identified.D9 device returned to manufacturer on 9/9/2024.

• Brand Name: CHEMOLOCK¿ PORT
• 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: 20185719
• Report Number: 9617594-2024-01279
• Device Sequence Number: 12937620
• Product Code: ONB
• 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,Followup
• Report Date (Section B): 10/24/2024

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: CL2100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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