MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHA; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3511
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, it is has not yet been received.
Event or Problem Description
The event involved a 30" (76 cm) appx 3.6 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, chemolock¿ w/red cap, bag hanger where the customer reported that the deice was leaking medication (unspecified) from a chemo lock connector while being administered to the patient.There were drips of the medicine on a small part on the floor.There was no human harm, no unprotected chemo exposure to patient or healthcare provider since it was spilled onto the floor and was cleaned right away.It was further stated that the healthcare provider was wearing ppe during the event.
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where the item #cl3511 is inside of a plastic bag and small drops of water are observed, however is no clear where is the source of the water.No additional anomalies are observed.One (1) used sample#cl3511 connected to mating device were returned for evaluation.As received no physical damage or anomalies were observed.The set #cl3511 was tested as per procedure and a leaks from the spinning mechanism was observed, the chemolock was cut and it was confirmed that the o-ring had been displaced.Complaint of leaks can be confirmed based on the used physical sample evaluation.The probable cause is due to an incorrect placement of the o-ring during manual process assembly during manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported event.

• Brand Name: 30" (76 CM) APPX 3.6 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK® PORT DRIP CHA
• 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: 18888659
• Report Number: 9617594-2024-00258
• Device Sequence Number: 7590741
• Product Code: ONB
• UDI-Device Identifier: 00887709057029
• UDI-Public: (01)00887709057029(17)280501(10)13643611
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/19/2024

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: CL3511
• Device Lot Number: 13643611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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
• Patient Sex: Unknown