MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" PRESSURE INFUSION EXT SET W/REMV MICROCLAVE® CLEAR,PURPLE CLAMP,ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33122-NS
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer, bulk non-sterile where it was reported that some of the intravenous (iv) start trays have the wrong extension sets.As a result, the flushes were not able to work on the extension set as it did not let any fluid go through them.There was unknown patient involvement, and unknown human harm.
Additional Manufacturer Narrative
The device is not available for evaluation; however, a photo was provided.Investigation is pending.D4: only di provided as lot number is unknown.Plots: 13551502 manufacturing date: 3/1/2023 expiration date: na bulk non-sterile.13692052 manufacturing date: 7/1/2023 expiration date: na bulk non-sterile.
Additional Manufacturer Narrative
No mc33122-ns product sample was returned for investigation.Customer did provide one (1) photo showing opened package, one set missing prime cap.Complaint of "flushes were not able to work on the wrong extension set as it did not let any fluid go through them." confirmed.A probable cause cannot be identified based on the information that has been provided and no sample to evaluate.Lot history review could not be returned due to unknown lot number.

• Brand Name: 7" PRESSURE INFUSION EXT SET W/REMV MICROCLAVE® CLEAR,PURPLE CLAMP,ROTATING LUER
• 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: 20038001
• Report Number: 9617594-2024-01173
• Device Sequence Number: 17769292
• Product Code: FPA
• UDI-Device Identifier: 00887709037403
• UDI-Public: 00887709037403
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: MC33122-NS
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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: FLUSH, UNK MFR
• Patient Sex: Unknown