MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 UNITS OF SPIROS® CLOSED MALE LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-H2457

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Event Description

The event involved a 25 units of spiros® closed male luer where it was reported that the customer was using this equipment on the cytotoxic reconstitution unit, on two occasions, a small white piece got stuck at the exit of the spiros.The syringes had to be remade.There was no exposure to any hazardous substance, the preparation was done in the isolator.There was no patient involvement, and no patient harm.This captures the first of two occurrences.

Manufacturer Narrative

One used spiro, list #011-h2457 connected with 5ml syringe were returned or evaluation.As received a white particulates inside and outside the spiro were confirmed.There was no internal damage on the spiro or the syringe.No white components on the spiros assembly were confirmed that might be the small white particulate observed.The origin of the white particulates suggest to be originated from an external mating device.However, no mating device was returned that would have been connected to the tip of the spiros.Complaint of particulate matter can be confirmed based on the particulates observed on the returned sample.However, without the return of the mating device a probable cause cannot be determined.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.D9: device returned to manufacturer on 9/14/2023.

• Brand Name: 25 UNITS OF SPIROS® CLOSED MALE LUER
• 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: 17700094
• MDR Text Key: 322856181
• Report Number: 9617594-2023-00661
• Device Sequence Number: 1
• Product Code: FMG
• 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,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2457
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 CYTOTOXIN, UNK MFR; UNSPECIFIED SYRINGE, UNK MFR