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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The complaint event occurred on an unspecified date and 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.A compounding technician at the facility reported that a small piece of hair was floating in the drip chamber of a secondary set chemolock after spiking and circle priming with an icu medical d5w 500ml iv bag.The hair was reported to be in one piece, brown, an inch long, and thin.The product was sealed and was stored in clean buns.There was no patient involved in the event and there was no report of human harm.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: one used list #cl3511, 30" (76 cm) appx 3.6 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, chemolock¿ w/red cap, bag hanger; lot #13643611.One used list #unknown, icu medical 5% dextrose injection, usp 500 ml intravenous bag; lot #1005361.As received, the presence of strand of hair floating inside the returned device's drip chamber was confirmed.No additional damage or anomalies were confirmed.The customer's complaint of particulate matter can be confirmed.The probable cause was due to gowning error controls during the manufacturing process at the supplier facility.The lot production history records were reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18041234
• Report Number: 9617594-2023-00901
• Device Sequence Number: 20700159
• Product Code: ONB
• UDI-Device Identifier: 00887709057029
• UDI-Public: (01)00887709057029(17)280501(10)13643611
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/10/2023

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: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEXTROSE, 5%INH20, (D5W) 500ML IVBAG, MFR ICU MED
• Patient Sex: Unknown