MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") SMALLBORE PUR YELLOW EXT SET W/1.2 MICRON FILTER, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	011-H3608
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information found in b5.
Event or Problem Description
An update was received on september 03,2024 stating that there were no visible signs of malfunction, damage, or problems, the device was directly primed with parenteral nutrition, the filter was not cracked, there was no problem with the pump, the pump used was an agilia pump, the device was stored dry at the room temperature.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.G4: model number is not sold in the us but similar device is sold under catalog number b1704.This product was used for the di and 501k.
Event or Problem Description
The complaint/event involved a 15 cm (6") smallbore pur yellow ext set w/1.2 micron filter, luer lock.At the pediatric gastro-nutrition unit, a child was receiving parenteral nutrition via a pump that was programmed for 20hours.It was reported that the pump alarmed after 1500 ml have been administered out of 3000 ml.Upon the inspection, a wet and saturated filter was found to be responsible for the interruption of the administration.A rinse of the child's central catheter (picc line with double lumen) and the change of the infusion setup were performed.There were no clinical consequences for the patient, but there was an increased risk of infection.A second filter of a different reference was used, allowing the continuation of the child's feeding.This issue was reported previously by the facility.There was no report of human harm.
Additional Manufacturer Narrative
D9 - date returned to mfg on 10/14/2024.Received one used list# 011-h3608, 15 cm (6") smallbore pur yellow ext set w/1.2 micron filter.As received infusate residue was observed on the outside of the filter as well as throughout the whole set.The inlet and outlet filter appeared to be wetted out with prior infusate.The sample was primed and leaked tested.Flow was successfully established, and leak was observed from the outlet filter the complaint of occlusion cannot be confirmed or replicated.During investigation a leak was observed from the filter.The probable cause of the leak is due to a temporary or complete loss of hydrophobic properties of the filter material due to an infusate interaction during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 15 CM (6") SMALLBORE PUR YELLOW EXT SET W/1.2 MICRON FILTER, LUER LOCK
• 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: 20008628
• Report Number: 9617594-2024-01159
• Device Sequence Number: 17933066
• Product Code: FMG
• UDI-Device Identifier: 00887709068742
• UDI-Public: 00887709068742
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

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: 011-H3608
• Device Lot Number: 13918217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 11/05/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/23/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED INFUSION PUMP, MFR UNK.; UNSPECIFIED PARENTERAL NUTRITION, MFR UNK.; UNSPECIFIED PICC LINE WITH DOUBLE LUMEN, MFR UNK.
• Patient Sex: Unknown