MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 84" (213 CM) 10 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/PRE-SLIT PORT, MICRO; STOPCOCK, I.V. SET

Model Number	MRSA10-84
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	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 84" (213 cm) 10 drop, vented/non-vented gravity admin set w/pre-slit port, microclave¿ clear, rotating luer where it was reported paramedics spiked 1l intravenous (iv) bag, squeezed drip chamber which filled with fluid.They released the roll clamp to allow fluid to fill the line.No fluid entered the tubing, even with pressure on the bag.Upon closer examination, they found a piece of debris at the top of the tubing just under the drip chamber which was occluding the line.They spiked another bag and the same exact thing happened, except when they applied pressure to the bag, the debris broke free and allowed fluid to flow.Neither bag or iv tubing was ever attached to a patient.There was no report of patient involvement or patient harm.This captures second of two occurrences.
Additional Manufacturer Narrative
The device is available for evaluation.However has not been received.
Additional Manufacturer Narrative
One new.List #mrsa10-84, 84" (213 cm) 10 drop, vented/non-vented gravity admin set w/pre-slit port, microclave¿ clear, rotating luer, approx priming volume: 10.5 ml; lot #5238827.One new.List #mrsa10-84, 84" (213 cm) 10 drop, vented/non-vented gravity admin set w/pre-slit port, microclave¿ clear, rotating luer, approx priming volume: 10.5 ml; lot #5227564.Each of the returned mrsa10-84 admin sets were fully primed without difficulty and without any instance of debris being observed.The complaint was unable to be replicated or confirmed.
Event or Problem Description
Additional information received stating that the debris was inside the line obstructing the fluid path.

• Brand Name: 84" (213 CM) 10 DROP, VENTED/NON-VENTED GRAVITY ADMIN SET W/PRE-SLIT PORT, MICRO
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16451215
• Report Number: 9617594-2023-00090
• Device Sequence Number: 14911589
• Product Code: FMG
• UDI-Device Identifier: 00887709079373
• UDI-Public: (01)00887709079373(17)261001(10)5633216
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/02/2023

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 Expiration Date: 10/01/2026
• Device Model Number: MRSA10-84
• Device Catalogue Number: MRSA10-84
• Device Lot Number: 5633216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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: UNSPECIFIED INTRAVENOUS BAG, UNK MFR
• Patient Sex: Unknown