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 Problems Crack (1135); Disconnection (1171)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved a microclave¿ clear neutral connector and occurred on an unspecified date.It was reported when bedside rn, simran, went to disconnect tubing from lumen of picc to obtain labs, the tubing was difficult to disconnect.She noted that the luer connector was spinning but the slip tip of the tubing was somewhat stuck.She pulled a little harder to disconnect the tubing and then noted that the tip had broken off and remained in the needleless connector.Upon further inspection, not only was slip tip cracked and broken, but the luer collar was as well.There is no know trauma to the tubing.This lumen was infusing saline at 20 ml/hr and the last medication to have been infused was 20 meq of potassium chloride at 2000 the evening prior.Tpn/lipids were infusing via the other lumen.There was patient involvement, however, injuries or adverse event reported.

Manufacturer Narrative

The complaint on the mc100 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.

• 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: 18682909
• MDR Text Key: 335124468
• Report Number: 9617594-2024-00142
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: MC100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/11/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/09/2024
• 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: NORMAL SALINE, MFR UNK.; POTASSIUM CHLORIDE, MFR UNK.; TOTAL PARENTERAL NUTRITION, MFR UNK.