MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemolock¿ drip chamber, spiros® w/red cap, hanger.Leakage was reported at the connection point between the spiros and the tubing during infusion.The customer stated that the leak was due to the tubing failing or cracking.The set-up was replaced and therapy resumed.There was no harm to the patient associated with this complaint issue.This report reflects 5 same/similar instances.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
A video and photo were provided by the customer showing leakage at the spiros.5 used cl3011 drop admin set w/integrated chemolock drip chamber, spiros and various mating devices were provided by the customer for inspection and investigation.Each of the five sets was leak tested per product specifications.There was leakage from each spiros.Examination of each spiros showed dislodged o-rings.The spiros was disassembled and visually examined and there was no damage on the post of the spiros.The reported complaint can be confirmed.The probable cause of the dislodged o-ring is unknown.The device history record was reviewed and no relevant nonconformities were identified that would have led to the reported complaint.Additional/updated information can be found in b3.G2 - report source: please disregard the selection of foreign from the initial emdr.This complaint is from usa.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER,
• 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: 19381934
• Report Number: 9617594-2024-00643
• Device Sequence Number: 15078133
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: (01)00887709057012(17)281101(10)13827909
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: CL3011
• Device Lot Number: 13827909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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