MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® CLEAR NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12512-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used.List #12512-01, microclave¿ clear neutral connector; lot #unknown.One (1) used, extension tubing with needle; confirmed presence of residual fluorouracil crystal upon inspection, no other physical damage or anomalies observed.Leak tested and confirmed customer complaint of leak.Separated then re connected mating device, retested and no leak observed.Probable cause, mating device not tightened properly.
Event or Problem Description
The event occurred on an unspecified date and involved a microclave® clear neutral connector.It was reported that an injection cap (microclave clear) that was on a patient and connected to a port that had chemo infusing at home.When they went to disconnect the pump from the patient on friday, they noted crystallization between the injection cap and port, which indicates that the chemo infusing had leaked out.It was also stated that the drug used was fluorouracil (5fu).They used phaseal and this happened above the closed system between where the injection cap connects to the huber needle tubing coming from the patient.No harm was reported.

• Brand Name: MICROCLAVE® CLEAR NEUTRAL CONNECTOR
• 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: 20075292
• Report Number: 9617594-2024-01204
• Device Sequence Number: 6414202
• Product Code: FPA
• UDI-Device Identifier: 00887709050532
• UDI-Public: 00887709050532
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• 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): 08/27/2024

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: 12512-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: FLUOROURACIL (5FU), MFR UNK.
• Patient Sex: Unknown