MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B90051
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
It was reported that a 9" (23cm) smallbore ext set w/0.2 micron filter, clave®, clamp, check valve w/luer lock was found to have disconnected during patient use.It was reported that there was a disconnection on the tubing and it was not glued.There was no patient harm reported.
Additional Manufacturer Narrative
No b90051product samples, videos or photographs were returned for investigation.The device history lot was not reviewed, no lot number information was provided.A probable cause cannot be identified based on the information that has been provided.Updated information in d9.

• Brand Name: 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/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: 20221318
• Report Number: 9617594-2024-01303
• Device Sequence Number: 7858287
• Product Code: FMG
• UDI-Device Identifier: 00887709011991
• UDI-Public: 00887709011991
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: B90051
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/15/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown