MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33038
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing.Leaking was reported when using the microclave while putting in an iv and attaching the device and then priming/flushing normal saline.The patient was receiving docetaxel and had drips on arm at connections, they used soap and water to wash.Their usual set up was with an unspecified angi cath and this j loop connected to non-pvc alaris tubing.There was also slight delay as the nurse donned ppe, switched out jloop and then administered rest of infusion.It was stated that they could not figure out if there may be a "crack" on the device or just part of the plastic that is supposed to be there.There was no harm as a result of the complaint issue.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e additional contact: (b)(6).
Additional Manufacturer Narrative
Corrected information can be found in h6 health effect - clinical code.
Additional Manufacturer Narrative
Received two used devices for evaluation.A crack was observed on each of the female luers of the samples.The reported complaint of a leak could be confirmed.The returned extension set was observed to have a crack on the female luer.The probable cause is due to a material issue on a vendor supplied part.The lot history was reviewed.No nonconformities were identified have contributed to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC
• 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: 21996194
• Report Number: 9617594-2025-00967
• Device Sequence Number: 8480021
• Product Code: FPA
• UDI-Device Identifier: 00887709037281
• UDI-Public: (01)00887709037281(17)291101(10)14218527
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2025

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: MC33038
• Device Lot Number: 14218527
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 04/11/2025; 08/08/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/09/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: DOCETAXEL, MFR UNK; NORMAL SALINE, MFR UNK; UNSPECIFIED ANGI CATH, MFR UNK; UNSPECIFIED NON-PVC IV TUBING/LINE, MFR ALARIS
• Patient Sex: Unknown