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	MC33213
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer that experienced leakage.The reporter stated that leaking was noted from tubing, and a new iv needed was placed due to unable to disconnect.The patient involved was 17.14 years old and female.The affected area or unit location was ct/cat scan.Thus, there was patient involvement, no human harm and unknown delay in therapy reported.
Additional Manufacturer Narrative
A2 - date of birth - the patients age was used to approximate the date of birth as (b)(6) 2008.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Received one (1) used list# mc33213, 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot# unknown one (1) used list# unknown, catheter; lot# unknown.A crack was observed on the female luer of the set.The reported complaint of a leak could be confirmed.The returned sample was observed to have a crack on the female luer.The probable cause is due to a material issue with a vendor-supplied part.A device history review (dhr) lot# review could not be conducted because no lot number(s) was/were identified.

• 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: 21661198
• Report Number: 9617594-2025-00526
• Device Sequence Number: 12923369
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: 00887709037519
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: MC33213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 17 YR
• Patient Sex: Female