MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number CH2000S-PC

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

Event Description

The event involved a spinning spiros® closed male luer, purple cap.The customer reported that a cytotoxic agent flowed on the thigh of the patient because the device material had split.This occurred during administration of herceptin sc and potentially, an additional infusate that was cytotoxic.The incident was observed minutes after the infusion started.The device was not replaced.Although it was reported that the patient's therapy was completed, the drug was not fully administered and there was some loss of product that flowed through the crack.The leak was cleaned-up as per facility protocol, no specific kit used.There were no specific details to report on patient¿s condition other than the following: there was no human harm/adverse event, no delay in therapy, no blood loss and no need for medical intervention as a result of the reported issue.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16831625
• MDR Text Key: 314173673
• Report Number: 9617594-2023-00161
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)270501(10)5990779
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH2000S-PC
• Device Catalogue Number: CH2000S-PC
• Device Lot Number: 5990779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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: HERCEPTIN SC, MFR UNK; UNSPECIFIED CYTOTOXIC MEDICATION, MFR UNK