MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC33371
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A couple of photos were shared by the customer, in one photo a plastic bag with the number#: (b)(4) is shown, in the other photo a male luer separation from the rest of the set is observed, and no additional anomalies besides the mentioned are observed.One (1) used.List#: mc33371 was returned for evaluation.As received the male luer adaptor was observed to be separated from the rest of the set, both components were analyzed through ultraviolet (uv) light, and insufficient solvent applied evidence was confirmed.The tube and the male luer pocket were measured finding within specification.Complaint of disconnection can be confirmed, the probable cause was due to insufficient solvent applied during manual process assembly in ensenada.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
It was reported that a set extension 15in 1.2um filter 4.8pv content strl me1225 was found to have disconnected during patient use in unit 3 sw.The report stated that the patient's bifuse, which was infusing medications through their peripherally inserted central catheter (picc), popped off.The tubing disconnected from the port that was attached to the clave.A sample photo was provided showing the tubes were popped off from the clave.There was patient involvement and no injury.

• Brand Name: 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK
• 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: 20478067
• Report Number: 9617594-2024-01468
• Device Sequence Number: 8166346
• Product Code: FMG
• UDI-Device Identifier: 00887709038172
• UDI-Public: (01)00887709038172(17)290601(10)14041053
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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: MC33371
• Device Lot Number: 14041053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: PICC, UNK MFR.; UNSPECIFIED FLUID, UNK MFR.
• Patient Sex: Unknown