MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE CLEAR CONNECTOR

Model Number	011-C3300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Engineering evaluations were performed.Each of the two returned microclave connectors were disassembled and analyzed.The results and potential root causes were recorded as follows: microclave connector with the plug protrusion - silicone plug was damaged/cored on the top surface.Potential cause(s): plug protrusions of this nature have been known to occur when excessive back pressure are applied.Very high pressures can be generated with small syringes.Typical clinical usage recognizes the importance in isolating and clamping adjacent lines within the fluid circuit when high pressures are generated with small syringes.Microclave connector with the recessed plug - the plug initially remained adhered/stuck on the spike potentially suggesting insufficient lubricant on the silicone plug area of the seals.The plug and spike were able to be separated with some manipulation; cap showed evidence of internal fluid leakage between the cap and the plug.Potential cause(s): the engineers report suggests there may not have been adequate lubricant between the spike and the silicone plug which may have contributed to the recessed silicone issue.The report noted mfg.Trend records identify this type of mfg.Silicone lubrication errors to be isolated/extremely rare occurrence.Findings: the reported microclave component issues were confirmed.
Event or Problem Description
Int'l.(uk) complaint received reporting component issues with use of 011-c3300 microclave connectors and various picc and central line set-ups.The facility was trialing the microclave connectors (dec.2013 - jan.2014) and reported two component related issues where in one instance the silicone plug was recessed and one instance where the silicone plug was protruding.The microclave connectors were successfully pretested/primed and used without incident in multiple infusion treatments prior to the component reset issues that occurred.Related usage/set-up information reports the connectors were accessed/mated with 10ml luer lock syringes; anti-syphon syringe giving sets.The microclave connectors were removed and replaced with no adverse patient consequences and or outcomes.Device return: two (2) used 011-c3300, microclave connectors.No mating/access devices were returned.Visual inspection of the as-received devices recorded one microclave connectors silicone plug was protruded and one microclave silicone plug was recessed.The reported product issues were visually confirmed.

• Brand Name: MICROCLAVE CLEAR CONNECTOR
• Common Device Name: MICROCLAVE CLEAR CONNECTOR
• 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 (Section G): 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
• MDR Report Key: 19554770
• Report Number: 2025816-2014-00196
• Device Sequence Number: 15155014
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)180601(10)2696512
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/19/2013

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 Expiration Date: 01/06/2018
• Device Model Number: 011-C3300
• Device Catalogue Number: 011-C3300
• Device Lot Number: 2696512, 2704553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2014
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2013
• 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: CAY 10ML LUER LOCK SYRINGE; WESCOTT SAE-FLO MD MULTI DRUG ANTI-SYPHON SET 150
• Patient Sex: Unknown