MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, BIFUSE, PRESSURE INFUSION (400PSIG) W/2 CLAVE¿ CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-MC330684

Device Problem Material Deformation (2976)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The complaint/event involved a ext set, bifuse, pressure infusion (400psig) w/2 clave¿ clear.Staff reported that they identified rubber as extending from the end of the luer lock connection when staff went to flush site.They became aware of the issue when nurse went to scrub the hub on the device.There was an unspecified medication in use at the time of the complaint/event.Although there was patient involvement, there was no delay in therapy, no adverse event or harm as a result of the reported event.

Manufacturer Narrative

One photo was shared by the customer, there is observed on one of the shuntless a protruding seal condition, the second shuntless doesn¿t have any anomalies.One used sample item #011-mc330684 was returned for evaluation.As received the silicone was observed to be protruding out of the shuntless body.An unknown internal solution was observed inside.No mating devices was returned.The complaint of silicone sleeve protruding can be confirmed based on the physical sample and photo shared by the customer for evaluation.The probable cause is typically due to overpressure the device without activate the clamp.According to the dfu statement.- for sets equipped with clave/ microclave y site: prior to pressurizing, activate the slide clamp and give the pressure infusion through the clave/microclave y site.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 28dec2023.

• Brand Name: EXT SET, BIFUSE, PRESSURE INFUSION (400PSIG) W/2 CLAVE¿ CLEAR
• 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: 18309776
• MDR Text Key: 330947931
• Report Number: 9617594-2023-01122
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709123274
• UDI-Public: (01)00887709123274(17)280301(10)13589922
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330684
• Device Lot Number: 13589922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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: UNSPECIFIED MEDICATION/INFUSATE, MFR UNK