MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT; STOPCOCK, I.V. SET

Catalog Number	B33276
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 6" smallbore trifuse ext set w/3 microclave®, 0.2 micron filter, 3 clamps, rotating luer.A medsun medwatch uf/importer report # (b)(4), which stated: "total parenteral nutrition (tpn) filter noted to be leaking.Line switched out." the patient's age is 19 days old.Although there was patient involvement, there was no specific harm to the patient or staff harm reported.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e: additional reporting contact: (b)(6).
Additional Manufacturer Narrative
The customer complaint of leakage on item b33276 was confirmed, even though no product samples, pictures, or videos were received for investigation.Based on a lot history review, this lot has been involved in similar complaints.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.Updated information can be found in d9.

• Brand Name: 6" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 0.2 MICRON FILTER, 3 CLAMPS, ROTAT
• 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: 19397776
• Report Number: 9617594-2024-00676
• Device Sequence Number: 7753913
• Product Code: FMG
• UDI-Device Identifier: 00887709007192
• UDI-Public: (01)00887709007192(17)280901(10)13766552
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2024

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: B33276
• Device Lot Number: 13766552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
• Patient Age: 19 DA
• Patient Sex: Unknown