MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" BIFUSE EXT SET W/MICROCLAVE¿ CLEAR, 2 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC33368
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional initial reporter email: (b)(6).Initial reporter report came to icu medical through: the stevens company limited.(b)(6).The device was not returned for evaluation.Upon receiving the device, it will be investigated and a supplemental mdr submitted.
Event or Problem Description
An event involving a 6" bifuse ext set w/microclave¿ clear, 2 clamps, rotating luer experienced disconnection.As per report, the brand new y connector with blood port was added to iv line.When blood port side of y connector was unclamped the tubing popped out of the y junction opening the line and causing blood to backup in piv line.Piv immediately clamped before patient lost any blood, y connector removed from pre-existing lines and lines dead ended with sterile cap.Medication administration was delayed due to need to make new medline and prime new y connector.There was patient involvement, no human harm and there was delay in therapy.
Additional Manufacturer Narrative
One used list# mc33368, 6" bifuse ext set w/microclave¿ clear, 2 clamps, rotating luer was provided by the customer for complaint investigation.As received, one side of the device's port had dislocated tubing.There were some unknown solution residuals present as well.No other physical damage or anomalies were observed.The other port tubing was tested and passed, and the dimensions of the tubing and the bond pocket were measured and passed.Sufficient solvent observed on the tubing.The customer complaint of the tubing popped out of the y junction is confirmed.However, the probable causse in unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d8 - was device serviced by third party? and d10 concomitant product.D9 - date returned to mfg: 07jan2025.Updated information can be found in h6 component codes.

• Brand Name: 6" BIFUSE EXT SET W/MICROCLAVE¿ CLEAR, 2 CLAMPS, 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: 19938602
• Report Number: 9617594-2024-01097
• Device Sequence Number: 4875875
• Product Code: FMG
• UDI-Device Identifier: 00887709038141
• UDI-Public: (01)00887709038141(17)260601(10)5452795
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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 Expiration Date: 06/01/2026
• Device Catalogue Number: MC33368
• Device Lot Number: 5452795
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2021
• 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 PREEXISTING IV LINES, MFR UNK
• Patient Sex: Unknown