MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SEE SECTION H11; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	A1129
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/12/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Section d1 - brand name: 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, clamp, nanoclave® t-connector (purple ring), rotating luer.The device is reported to be available for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved 4 incidents where the 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, clamp, nanoclave® t-connector (purple ring), rotating luer devices leaked during patient administration of emergency medication/rapid blood administration on the same patient.The patient expired.The customer further reported that it was unclear if the connector couldn't handle the pressure from the rapid fluid devices.
Event or Problem Description
Additional information received stating 2 t-connectors started leaking with administration of rapid blood administration, and t-connector started leaking with administration of flush.
Additional Manufacturer Narrative
Received four (4) used a1129 smallbore pressure infusion (400psig) ext sets and one (1) used list#: unknown catheter mated to one (1) of the sets for inspection.A crack was observed on the female luer on three (3) of the a1129 sets.A crack was observed on the catheter mated to the one (1) used set with no crack.Each set was leak tested per product specifications.There was leakage from the cracks on each set.The reported complaint can be confirmed on three (3) of the returned used a1129 sets.The probable cause of the crack and subsequent leakage is due to a material issue on a vendor supplied part.The reported complaint could not be confirmed on the one (1) used a1129 mated to the list#: unknown catheter.The crack and subsequent leakage was on a non-icu medical part.There were no defects or anomalies on the a1129.The reported lot history and a lot of the packaging was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Corrective actions are in process.Additional information in b5.D9 device returned to manufacturer on 3/6/2025.

• Brand Name: SEE SECTION H11
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 21702096
• Report Number: 9617594-2025-00562
• Device Sequence Number: 7696022
• Product Code: FPA
• UDI-Device Identifier: 00887709068193
• UDI-Public: (01)00887709068193(17)010929(10)14144054
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A1129
• Device Lot Number: 14144054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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 MEDICATION, MFR UNK.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown