MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MS930
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that, on an unspecified date, a 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿, clamp, rotating luer was found to have a crack resulting in a leak during patient use.The reporter stated that the end of the tubing was cracked and when they flashed saline the extension set either dripped or sprayed out.There was no patient harm reported.The initial reporter indicated that the event occurred three times; however, no additional information was given pertaining to the additional instances.A search of the complaint database showed no prior report of these events.
Additional Manufacturer Narrative
Received two (2) photos showing the d1000 tego.There appeared to be a small amount of seal tearing present on the seals.The reported complaint of the tegos being stripped can be confirmed.The probable cause of the torn seal is due to variation on tego seal material which has a direct impact on functional performance of the tego connector with an additional contributing factor regarding uneven adhesive application.Corrective and preventative actions are in process.Lot history review was reviewed and no relevant nonconformities were found that would have led to the reported complaint.

• Brand Name: 7.5" (19 CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE®, CLAMP, ROTATING
• 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: 21602155
• Report Number: 9617594-2025-00470
• Device Sequence Number: 13053929
• Product Code: FPA
• UDI-Device Identifier: 00842472100730
• UDI-Public: (01)00842472100730(17)290901(10)14137236
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/09/2025

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: MS930
• Device Lot Number: 14137236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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: NORMAL SALINE, BD.
• Patient Sex: Unknown