MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 129" (328 CM) APPX 16.4 ML, 15 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, REMV 4-WAY; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	Z3626
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
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 129" (328 cm) appx 16.4 ml, 15 drop primary set w/bcv-clave®, clave®, remv 4-way stopcock w/microclave®, rotating luer w/filter cap, 2 ext.The customer reported that the device was leaking from the connection between tubing and the iv when product is in use.The customer stated that the device did not appear to have any physical damage.There was unknown patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The complaint on the z3626 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history review was performed and no non-conformities were found that would have led to the reported complaint.

• Brand Name: 129" (328 CM) APPX 16.4 ML, 15 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, REMV 4-WAY
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 19623836
• Report Number: 9617594-2024-00832
• Device Sequence Number: 15505223
• Product Code: FPA
• UDI-Device Identifier: 00887709034082
• UDI-Public: (01)00887709034082(17)290201(10)13905517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K974589
• Number of Events Summarized: 1
• Summary Report (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): 08/22/2024

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: Z3626
• Device Lot Number: 13905517
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Patient Sex: Unknown