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 CHEMOCLAVE® DRIP CHAMBE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3011
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture was returned showing an administration set with what appears to be black spots throughout the tubing of the set.The set has fluid inside.Received one used list# ch3011 admin set.As received an unknown black contamination spots were observed throughout the whole set.Glucose solution was also observed throughout the set.This product goes through e-beam sterilization.The complaint of black contamination can be confirmed.Due to the glucose fluid found in the set the source of the contamination cannot be determined.
Event or Problem Description
The event involved a 30" (76 cm) appx 3.3 ml, 20 drop admin set w/integrated chemoclave® drip chamber, spiros® w/red cap, bag hanger where the customer reported that a patient was placed in the secondary set through which only glucose solution 10 % passed, it was observed growth of black balls with hairs, suspicious of some microorganism, 48 hours after use.They are looking for discard that it is not a problem of the set.The glucose solution was administered for 40 hours, and the problem was noticed when handling it at the time of going to use the set.The product status during the event was during use.There was patient involvement, and no one was harmed in the event.Also, there was no adverse event and no delay in therapy.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOCLAVE® DRIP CHAMBE
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19991929
• Report Number: 9617594-2024-01141
• Device Sequence Number: 20968347
• Product Code: ONB
• UDI-Device Identifier: 00840619023966
• UDI-Public: 00840619023966
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173477
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

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: CH3011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GLUCOSE SOLUTION, MFR UNK.
• Patient Sex: Unknown