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 Code	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
B3: date of event: the date of event is unknown but in february, and 01 feb 2025 has been used as a placeholder.Investigation summary: one video and one photo were shared by customer, where a leak coming from the female luer is shown, no additional damage or anomalies were observed.Forty (40) new.List#: ms930, 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿ were returned for evaluation.No physical damage or anomalies were observed.No mating device was returned.Based on the binomial stages sampling to represent the lot population 35 samples were visually inspected looking for crack on femal luer, only in 3 samples with an anomaly was noted.The 3 samples with the worst condition were tested as procedure and no leak were noted.Complaint of leaks can be confirmed based on the video and photos shared by customer.The probable cause is due to a material issue on a vendor supplied part.The lot history and the lot history of the sister samples were reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
A complaint was received regarding the 7.5" (19 cm) appx 0.31 ml, smallbore ext set w/remv clave¿, clamp, rotating luer that experienced leakage.The reporter stated that a few of the product was leaking with iv fluids.It was further stated that unknown iv fluid was involved.The event date was on feb-2025.There was patient involvement and no adverse event.Update: the one leaky example they kept (there were 4-5 occurrences) was discarded.

• 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: 22107166
• Report Number: 9617594-2025-01121
• Device Sequence Number: 8149841
• Product Code: FPA
• UDI-Device Identifier: 00842472100730
• UDI-Public: (01)00842472100730(17)291101(10)14218145
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 05/29/2025

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: 14218145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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