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

Catalog Number MC100

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.Lot history review cannot be performed as the lot number is unknown.Section e1 - (b)(6).

Event Description

The event occurred on an unspecified date and involved a microclave® clear neutral connector.The customer reported that their teams are reporting an issue with the total parenteral nutrition (tpn) tubing; it is disconnecting unexpectedly during patient use.The customer stated that senior staff verify the connections are secure, but they still seem to pop off.3y has saved the product and packaging.Alaris tubing 10010453 or 2432-0007 being used with mc100.The event occurred while in use with patient.The device was operated by a health professional.There was patient involvement and there was unknown patient harm.Sample is available for investigation.Amsuello (b)(6) 2023.

Event Description

The event occurred on an unspecified date and involved a microclave® clear neutral connector.The customer reported that their teams are reporting an issue with the total parenteral nutrition (tpn) tubing; it is disconnecting unexpectedly during patient use.The customer stated that senior staff verify the connections are secure, but they still seem to pop off.Alaris tubing 10010453 or 2432-0007 being used with the device.There was patient involvement, however, harm was not reported as a consequence of this event.

Manufacturer Narrative

Correction b5, d10, e1.

• Brand Name: MICROCLAVE¿ CLEAR NEUTRAL CONNECTOR
• Type of Device: 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: 18268730
• MDR Text Key: 330024045
• Report Number: 9617594-2023-01072
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: MC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALARIS TUBING 10010453 OR 2432-0007.