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

Model Number CH2000S-PC

Device Problems Contamination (1120); Particulates (1451)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

The event involved a spinning spiros closed male luer, red cap in which the customer reported that they tried using a vial spike and noticed a small fragment of clear plastic along with a hole that can be seen when disconnected from the spiros.The customer suspects that spiros device may cause the silicon to become loose.It was not specified whether there was patient involvement or not.No harm was reported as a consequence of this event.

Manufacturer Narrative

The device was discarded and not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Additional telephone number - section e1 (b)(6).

Manufacturer Narrative

A photo was provided for evaluation; the complaint of cored seal on a a clave can be confirmed based on the photos provided.The photo showed clave (concomitant product) with a cored silicone seal.No spiros can be observed in the photos provided.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review for lot 5957596 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, RED 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: 16860184
• MDR Text Key: 314456570
• Report Number: 9617594-2023-00172
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)270501(10)5957596
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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-C
• Device Lot Number: 5957596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• 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: VIAL SPIKE, LIST # 011-CH74 - ICU MEDICAL.