MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM; STOPCOCK, I.V. SET

Catalog Number MC330027

Device Problem Disconnection (1171)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

The event involved a 7" (18 cm) appx 0.52 ml, smallbore trifuse ext set w/3 microclave® clear, 3 clamps, luer lock where it was reported the patient's line disconnected.The registered nurse noticed that tubing in connection point between 3 clamps and luer lock had come out.The time of the incident patient had a warm pack on top of line which may have contributed to breakage.Line had been in use for 84 hours and was due to be changed that day (b)(6) 2023 at 1400.Line was running hydromorphone mixed in d5w (concentration of 200mcg/ml) for a patient controlled anesthesia (pca) bolus dose with nacl 0.9% running continuously at 10ml/hr.There was also intermittent metoclopramide (concentration 1mg/ml) running 4 times a day, and amoxicillin-clavulanic acid (concentration 10mg amoxicillin/ml) twice a day.There was patient involvement however no adverse event reported.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Additional contact: (b)(6).

Manufacturer Narrative

The complaint of disconnection / loose connection on item mc330027 cannot be confirmed by investigation.Since 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 probable cause cannot be determined.The device history review (dhr) reviewed couldn't be performed due to lot number for this complaint was unknown.

• Brand Name: 7" (18 CM) APPX 0.52 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR, 3 CLAM
• Type of Device: STOPCOCK, I.V. SET
• 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: 18380391
• MDR Text Key: 331361276
• Report Number: 9617594-2023-01188
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: MC330027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/19/2024
• 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: AMOXICILLIN-CLAVULANIC ACID, UNK MFR; HYDROMORPHONE MIXED IN D5W, UNK MFR; METOCLOPRAMIDE, UNK MFR; NACL 0.9%, UNK MFR