MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	A1129
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used partial.List #a1129, 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.One used.List #unknown, purple connector.As received a visible crack was observed on both returned samples.Both sets were tested as per procedure and leaking from the crack on both the female luer was confirmed.The complaint of leaking issues with t-connector can be confirmed.The probable cause of the crack is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The complaint/event involved a 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.Leakage of an unspecified infusate was reported with the t-connector (where the male adapter connects) while hand flushing in the emergency department.There was no report of human harm.A second device was returned for evaluation, confirming a crack.

• Brand Name: 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI
• 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: 21193280
• Report Number: 9617594-2025-00154
• Device Sequence Number: 8786568
• Product Code: FPA
• UDI-Device Identifier: 00887709068193
• UDI-Public: (01)00887709068193(17)290801(10)14095918
• 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
• Report Date (Section B): 01/20/2025

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: A1129
• Device Lot Number: 14095918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/20/2025
• 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 INFUSATE, MFR UNK
• Patient Sex: Unknown