MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3020
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	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.However; the investigation is not yet complete.Initial reporter phone has an extension of (b)(6).
Event or Problem Description
The event occurred on an unspecified date involving a 40" (102 cm) appx 4.9 ml, admin set w/chemolock¿ w/red cap, 20 drop in-line drip chamber, spiros®, bag hanger, drop-in red cap where it was noticed a white sediment in the tubing.The customer added that when the tubing was cut open, the white matter can be removed which is a risk for patients.It was also stated that the product package was sealed and not expired.A systemic treatment has a very high turnover of product as they have high usage.The customer does not think this package has sat for long but unable to give an exact time frame the item are stocked daily from their stores.They started inspecting packages of cl3020 and multiple pieces had white sediment present (different lot number).There was no patient involvement and no patient harm.
Additional Manufacturer Narrative
Received one used list #cl3020, 40" (102 cm) appx 4.9 ml, admin set w/chemolock¿ w/red cap, 20 drop in-line drip chamber, spiros®, bag hanger, drop-in red cap; lot #5333880.The residual solvent in the inside of the tubing adjacent to the proximal bond port to the inline drip chamber is confirmed in the returned cl3020 administration set assembly.Subsequent investigation and testing showed that the residue of the dissolved white bond port solidified on the inside diameter of the clear tubing but was not present or observed when the fluid path was flushed and filtered after the tube was manipulated in the area of the residue.After cutting open the tubing and exerting heavy tube rubbing over the internal surface of the tube some of the white residue could flake off or be scraped off.The probable cause of the residual solvent is excessive solvent application during manual bonding in manufacturing.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 40" (102 CM) APPX 4.9 ML, ADMIN SET W/CHEMOLOCK¿ W/RED CAP, 20 DROP IN-LINE DRIP
• 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: 15147173
• Report Number: 9617594-2022-00221
• Device Sequence Number: 20301943
• Product Code: ONB
• UDI-Device Identifier: 00887709072923
• UDI-Public: (01)00887709072923(17)260501(10)5333880
• 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): 07/08/2022

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 Expiration Date: 05/01/2026
• Device Model Number: CL3020
• Device Catalogue Number: CL3020
• Device Lot Number: 5333880
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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