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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: additional phone number: (b)(6).The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with regards to a 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing that experienced leakage.The reporter stated that they encountered another device that leaked at the clave out of the package (mc33038).They switched for another clave, but it still leaked.Both claves were secured tightly on this clean, dry extension loop.There is no crack in any of the devices that they can see.The event date was unknown.Sample photos were provided that showed the involved products inside the packaging with the product's information.The event date was on 11-jan-2025 during priming after opening the package.There was patient involvement, no adverse event and no delay in therapy.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: two used list #mc33038, 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing; lot #14149835.One used partial list #mc33038, 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing; lot #14149835.One new list #mc33038, 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing; lot #14149835.Two pictures of the samples packed in a bag for delivery.The pictures were reviewed.One of the smallbore pressure infusion ext sets can be seen to have its microclave removed from the female luer.No damage can be clearly discerned.Two microclaves are also pictured as loose in the bag.One of the used sets had its microclave removed.A crack was observed on the knit line of the female luer of that set.One extra clave was received.No other defects or anomalies were observed.The two used sets were tested as per specification and leaking from the crack on the female luer of the damaged set was confirmed.No other sets were observed to leak.The complaint of leaking can be confirmed, but only on the set with the cracked female luer.The probable cause of the crack is due to a material issue on a vendor supplied part.There is a capa that is related to this complaint issue.The lot history of the returned samples was reviewed.No nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in e3 and e4.

• 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: 21341162
• Report Number: 9617594-2025-00252
• Device Sequence Number: 7835920
• Product Code: FPA
• UDI-Device Identifier: 00887709037281
• UDI-Public: 00887709037281
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/03/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 02/09/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DRUG , MFR UNK
• Patient Sex: Unknown