MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE¿, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B9286
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	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a to 112" (284 cm) appx 14.4 ml, 15 drop primary set w/3 microclave¿, rotating luer that experienced particulate matter in the fluid path.It was reported that they have a contaminated item.Photo of the actual defective item was provided.Both lot numbers 14246714 and 14224719 are in contention for containing the compromised iv tubing.These were the two opened packages for the preop suite in the trash.The primary nurse was unable to identify which of the two lot numbers contained the defective tubing.The date of incident was on (b)(6) 2025.The primary nurse did not notice the problem while priming the fluids.During the fluids infusion, the secondary nurse noticed the problem.The patient involved was receiving the iv fluids prior to stopping the infusion to evaluate the defect when a secondary nurse observed the problem.The secondary nurse was unable to remove it from the outside of the device with an alcohol swab and unhooked the patient and got an entire new line set of a different manufacturer and initiated iv therapy.Afterwards, the secondary nurse attempted to open the inside and determine if it was on the inside of the tubing but could not remove the defect by any means of sanitization.No immediate harm transpired to the patient that was observed while in care at the surgery center.
Additional Manufacturer Narrative
Possible lot numbers: 14246714 (mfg date: 12/01/2024, exp date: 12/01/2029).14224719 (mfg date: 11/01/2024, exp date: 11/01/2029).The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
One photo was provided by the customer that confirms the complaint of contamination.Received one used device for evaluation.Burnt embedded material was observed on the drip chamber of the set.The drip chamber as received was cut open and the material was confirmed to be embedded in the wall and not loose in the fluid path.The reported complaint can be confirmed.The probable cause is due to a molding error from the vendor.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 112" (284 CM) APPX 14.4 ML, 15 DROP PRIMARY SET W/3 MICROCLAVE¿, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• 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: 21956590
• Report Number: 9617594-2025-00899
• Device Sequence Number: 7265338
• Product Code: FMG
• UDI-Device Identifier: 00840619045876
• UDI-Public: (01)00840619045876(17)291201(10)14246714
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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): 06/16/2025

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: B9286
• Device Lot Number: 14246714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/04/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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