MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC3325
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18cm) appx 0.67ml ext set w/remv microclave® clear, clamp, rotating luer where the customer used this device for all of their intravenous (iv's) in endoscopy.From there when trying to hook up the iv fluid line to the extension lock and you cannot push meds through the iv.If you take the extension cap off and run the iv the tubing direct to the line it will work.The problem is recurring.Additionally, the customer stated that an iv fluid was ringers lactate and then they tried to push propofol and fentanyl but could not push.Once they removed the lock device and hook the iv up directly, they could push the medication.There was patient involvement and no adverse event reported.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.Additional contact information: (b)(6).
Additional Manufacturer Narrative
The reported complaint of occlusion was not confirmed.No visual anomalies were observed on the returned set.The sample was hydrostatically pressure leak tested and no leaks were observed.The product had performed per the specifications.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18CM) APPX 0.67ML EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• 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: 17967511
• Report Number: 9617594-2023-00858
• Device Sequence Number: 7530706
• Product Code: FMG
• UDI-Device Identifier: 00887709037540
• UDI-Public: (01)00887709037540(17)280701(10)13692067
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: MC3325
• Device Lot Number: 13692067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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: FENTANYL, MFR UNK.; PROPOFOL, MFR UNK.; RINGERS LACTATE, MFR UNK.
• Patient Sex: Unknown