MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3.5" (9 CM) APPX 0.74 ML, SMALLBORE QUADFUSE EXT SET W/4 REMV MICROCLAVE® CLEAR,; STOPCOCK, I.V. SET

Catalog Number	MC330440
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a 3.5" (9 cm) appx 0.74 ml, smallbore quadfuse ext set w/4 remv microclave¿ clear, 4 clamps (red, white, blue, yellow), rotating luer experienced a disconnection during patient use.It was reported that when disconnecting the intravenous (iv) tubing from the microclave, the iv tubing snapped inside the microclave, and part of the iv tubing was still retained inside the microclave.A screenshot has been provided showing the item and lot number of the defective product and the description of the issue.The separation/disconnection occurred at the hub/microclave of the port with the yellow clamp.The tubing was infused with 5% dextrose in lactated ringer's (d5 lr).No blood loss or bleedback.The tubing/quad extension was replaced.Sample photos have been provided showing the set-up.There was a patient involved, no harm, and no delay in therapy.
Additional Manufacturer Narrative
One (1) used.List #unknown, lactated ringer's and 5% dextrose injection usp baxter 1000 ml intravenous bag connected to one (1) used, infusion set and one (1) used list #mc330440, connected to one (1) used, t-connector with microclave were returned for evaluation.As received a broken male luer was observed to be stuck inside the activated microclave, and the broken part of the male luer was found in the mating device.White stress marks were observed in the broken parts.Complaint of separation can be confirmed.The probable cause is due to unintentional twisting bending force applied during use.The device history for lot# 13677677 was reviewed and no nonconformities were found that would have led to the reported condition on the complaint.D9 - date returned to mfg: 5/6/2024.

• Brand Name: 3.5" (9 CM) APPX 0.74 ML, SMALLBORE QUADFUSE EXT SET W/4 REMV MICROCLAVE® CLEAR,
• 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: 19150174
• Report Number: 9617594-2024-00474
• Device Sequence Number: 9438008
• Product Code: FMG
• UDI-Device Identifier: 00887709088771
• UDI-Public: (01)00887709088771(17)280601(10)13677677
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/14/2024

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: MC330440
• Device Lot Number: 13677677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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: 5% DEXTROSE IN LACTATED RINGER'S (D5 LR), UNK MFR
• Patient Sex: Unknown