MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12"(30CM)APPX 0.77ML, SMALLBORE EXT SET W/CLAVE®, 0.22 MICRON FILTER, CLAMP, ROT; STOPCOCK, I.V. SET

Catalog Number	Z2599
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 12"(30cm) appx 0.77ml, smallbore ext set w/clave®, 0.22 micron filter, clamp, rotating luer in which the customer reported that taxol was infusing via primary tubing and 0.2-micron filter.The pump kept alarming saying downstream occlusion.When this nurse assessed the iv and tubing, the filtered tubing was found to be leaking at the site of the filter with the arrow on it.This tubing was then thrown out and new tubing as applied.The chemo spill was cleaned per policy.The defective item was discarded before pictures could be taken.Harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
E1 - additional contact telephone number - (b)(6).The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.

• Brand Name: 12"(30CM)APPX 0.77ML, SMALLBORE EXT SET W/CLAVE®, 0.22 MICRON FILTER, CLAMP, ROT
• 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: 21044986
• Report Number: 9617594-2024-01902
• Device Sequence Number: 3279324
• Product Code: FMG
• UDI-Device Identifier: 00887709027091
• UDI-Public: (01)00887709027091
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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
• Report Date (Section B): 12/30/2024

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: Z2599
• 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: 12/03/2024
• Initial Report FDA Received Date: 12/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TAXOL, MFR UNK
• Patient Sex: Unknown