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

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.However has not been received.

Event 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 one of two occurrences.

Manufacturer Narrative

Twenty-eight 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 #5633216.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.The device history review (dhr) for lot 5633216 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

Event 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
• Type of Device: 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: 16451214
• MDR Text Key: 310322882
• Report Number: 9617594-2023-00089
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709079373
• UDI-Public: (01)00887709079373(17)261001(10)5633216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED INTRAVENOUS BAG, UNK MFR.