MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 124" (315 CM) APPX 16.3 ML, 10 DROP PRIMARY SET W/3 CLAVE®, REMV 2 GANG 4-WAY ST; STOPCOCK, I.V. SET

Catalog Number	B9461
Medical Device Problem Codes	Infusion or Flow Problem (2964); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date and involved a 124" (315 cm) appx 16.3 ml, 10 drop primary set w/3 clave¿, remv 2 gang 4-way stopcocks, rotating luer, 1 ext.The customer reported that they were having issues with kinked tubing for quite some time.The customer further reported that this issue has occurred with different sets and lots and can sometimes cause slow delivery of medications and fluids, to complete blockages.The kinks can be seen in multiple different sets.Harm was not reported as a consequence of the events.
Additional Manufacturer Narrative
A series of photos were provided showing (b)(6) tubing sets.Kinks were observed in the tubing.It is unknown if the kinks caused issues in flow without the return of the device.The reported complaint of kinks can be confirmed.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Lot history review could not be reviewed due to the unknown lot number.

• Brand Name: 124" (315 CM) APPX 16.3 ML, 10 DROP PRIMARY SET W/3 CLAVE®, REMV 2 GANG 4-WAY ST
• 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 ; CS 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20026703
• Report Number: 9617594-2024-01163
• Device Sequence Number: 7476971
• Product Code: FMG
• UDI-Device Identifier: 00887709013964
• UDI-Public: 00887709013964
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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,Followup
• Report Date (Section B): 10/02/2024

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: B9461
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/02/2024
• 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