MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MC33213; 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	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding an unspecified icu medical clave that experienced leakage during patient use.It was reported that the clave, which was attached to the end of central line, was found to be leaking on the inside with tpn and lipids.The clave was removed and replaced.The number of occurrences is two.The clave was attached to the end of a central line and found to be leaking; upon discovery clave was immediately removed and replaced.Photo of the actual defective product was provided (tpn/lipids was found inside of the clave).There was no harm as a result of the event, however, did require access to the sterile, central line to replace the clave.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: -a photo showing the affected sample.No conclusions could be made from the photo.-one 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 new list #unknown, aquastat 10ml syringe; lot #kh05011.A crack was observed on the returned extension set female luer.No other damages or anomalies were observed.The reported complaint of a leak could be confirmed.The received 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.A dhr review could not be conducted because no lot number was identified.Updated information can be found in d1, d2a and d4.Corrected information can be found in d10, e3, e4.

• Brand Name: MC33213
• 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: 21945123
• Report Number: 9617594-2025-00876
• Device Sequence Number: 9122115
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: 00887709037519
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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): 06/29/2025

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: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TPN/LIPIDS, MFR UNK; UNSPECIFIED CENTRAL LINE, MFR UNK
• Patient Sex: Unknown