MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.46 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33327
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three new samples list # mc33327, 7" and 2 two new.Ref # (b)(4), b braun introcan safety 3 closed iv catheter 22 ga, were returned for evaluation.As received no physical damage or anomalies were observed.The returned samples were opened and connected into the returned catheter, no disconnection, issues or anomalies were observed.The samples were tested as per procedure and no leaks were observed.The male and female luers were measured finding within specification.Complaint of leaks at the connection cannot be confirmed or replicated.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event occurred on an unspecified date and involved a 7" (18 cm) appx 0.46 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock where it was reported the set was leaking.The leak occurred at the connection from the extension set leur to the catheter end externally from the patient.No hole, cut, tears noted, the site becomes loose at the connection site either during the infusion or at the end of the infusions.No blood loss or bleed back.The medication that leaked was chemotherapy with fluids.There was patient involvement and no harm, but patients and staff are being exposed to chemo leaks.

• Brand Name: 7" (18 CM) APPX 0.46 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®
• 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: 20522644
• Report Number: 9617594-2024-01491
• Device Sequence Number: 18135060
• Product Code: FPA
• UDI-Device Identifier: 00887709037762
• UDI-Public: (01)00887709037762(17)290701(10)14065026
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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: MC33327
• Device Lot Number: 14065026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: BRAUN INTROCAN SAFETY® 3 CLOSED IV CATHETER 22 GA.; UNSPECIFIED CHEMOTHERAPY, UNK MFR
• Patient Sex: Unknown