MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.38 ML SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, CHECK VA; STOPCOCK, I.V. SET

Catalog Number MC33691

Device Problem Material Separation (1562)

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 4" (10 cm) appx 0.38 ml smallbore bifuse ext set w/2 microclave® clear, check valve, 2 clamps (red,white), rotating luer and occurred on a unspecified date.It was reported total parenteral nutrition (tpn) and lipids disconnected from patient as bi-fuse connection completely severed from cap.Medication stopped, staff notified ql , csn and fellow.D10w started in the interim as tpn was off.There was patient involvement no harm reported.

Manufacturer Narrative

One (1) photo was shared by the customer, where a tube separation is observed from one of the shuntless microclave, no additional damage or anomalies are observed.One (1) used sample #mc33691 was returned for evaluation.As received a tube separation was observed from the shuntless microclave, the tube was observed through uv light and insufficient solvent coverage was confirmed.No damage or excessive force being applied was observed on the sample.The od of the separated tube and the id of the shuntless microclave were measured, finding within specification.Complaint of separation can be confirmed.The probable cause is due to insufficient solvent applied during manual assembly.

• Brand Name: 4" (10 CM) APPX 0.38 ML SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, CHECK VA
• 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: 18755103
• MDR Text Key: 336866629
• Report Number: 9617594-2024-00175
• 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,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC33691
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• 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: LIPIDS, MFR UNK; TOTAL PARENTERAL NUTRITION, MFR UNK