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

Catalog Number	CL4131
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved a 30" (76 cm) appx 3.6 ml, admin set w/20 drop in-line drip chamber, chemolock¿ additive port, spiros¿ w/red cap which reportedly leaked.The customer stated that after the roller of the tubing was released normally, the spiros would stop the flow of the fluid, however, the fluid kept running.The nurse reported that the medication was leaking onto their chemo gloves.The medication involved was belatacept (nulojix).The tubing/setup was replaced using a different lot number and therapy resumed.The medication was also replaced.There was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One (1) used sample #cl4131 connected with an unknown, sodium chloride bag were returned for evaluation.There was not physical damage or anomalies observed on the sample.The set was tested and a leaks coming from spiro was confirmed.It was confirmed that the o-ring had been displaced from the original position.The o-ring was dissembled and no molding damage or anomalies were confirmed.Complaint of leaks can be confirmed.The probable cause for this condition is unknown.Lot history review was reviewed and no relevant commodities, discrepancies or anomalies were identified that might lead the condition reported by the customer.

• Brand Name: 30" (76 CM) APPX 3.6 ML, ADMIN SET W/20 DROP IN-LINE DRIP CHAMBER, CHEMOLOCK¿ AD
• 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: 18351280
• Report Number: 9617594-2023-01173
• Device Sequence Number: 6221601
• Product Code: ONB
• UDI-Device Identifier: 00887709095779
• UDI-Public: (01)00887709095779(17)280901(10)13772268
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: CL4131
• Device Lot Number: 13772268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: BELATACEPT (NULOJIX), MFR UNK.
• Patient Sex: Unknown