MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number SC9045

Device Problem Break (1069)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.E1 - initial reporter phone: (b)(6).

Event Description

It was reported that a 9" ext set w/0.2 micron filter, clamp, rotating luer experienced a break.The reporter stated the tube/set broke while being used with a patient.The set-up included a 250ml bag of normal saline spiked with a meter tubing, which was then attached to the filter.The medication involved was remicade.It was further reported that the tubing setup was not replaced and therapy was not resumed.The patient was informed of how much medication was left in the infusion bag.The patient only had what was left in the priming chamber.The patient was asked if she wished to continue with what was left, however, the patient denied it.No medication intervention was required, the patient was disconnected and went home.There was patient involvement and no human harm was reported, the patient just got upset for getting wet on her arm and leg.

• Brand Name: 9" EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING LUER
• 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: 18107889
• MDR Text Key: 328989120
• Report Number: 9617594-2023-00964
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709040625
• UDI-Public: (01)00887709040625(17)280701(10)13716157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SC9045
• Device Lot Number: 13716157
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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: NORMAL SALINE; REMICADE, UNK MFR