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 Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 05/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation- it has not been received.

Event Description

The event involved a 25 units of spiros® closed male luer.The patient involved was a 57-year-old patient who was hospitalized for a cure of chemotherapy induction for acute myeloblastic leukemia.On day 7 (big protocol) during infusion, appearance of a crack in the secure connector connected to the syringe of cytarabine attached to the electrical syringe (syringe + secure connector installed by the unit of cytotoxic reconstitution).The solute was found on the ground when the caregiver came.It was impossible for the nurse to remove the secure connector to put a new tubing.Connection of the next cytarabine syringe.Loss of solute and therefore of efficiency of the treatment.Personnel in contact with the cytotoxic product.There was patient involvement but no report of human harm.

Manufacturer Narrative

D9 - date returned to mfg on 8/9/2023.Received the following: - one used unit.List #011-h2457, 25 units of spiros® closed male luer; lot #11379844.- one (1) used.List #unknown, connector; lot #unknown.- one (1) used.List #unknown, 3 way stopcock with extension tubing; lot #unknown.- one (1) used.List #unknown, connector; lot #unknown.- one (1) used.List #unknown, 20 ml bd plastipak syringe; lot #unknown.- one (1) used.List #unknown, 60 ml syringe with cytarabine; lot #unknown.It was observed and confirmed that a single used 011-h2457 spinning spiros was broken at the ultrasonic weld.The female portion of the spinning spiros remained attached to a large 60ml luer lock syringe while the body and male portion of the spinning spiros remained attached to an unidentified stopcock assembly.The ultrasonic weld was examined and the energy directors had good melt and penetration around the circumference of the weld.The energy directors fractured which is a sign of a good weld.The probable cause of the spinning spiros untrasonic weld breakage is typical of unintentional bending forces applied during use.The device history report (dhr) for lot 11379844 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17106417
• MDR Text Key: 317768602
• Report Number: 9617594-2023-00231
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619018610
• UDI-Public: (01)00840619018610(17)271001(10)11379844
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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: 11379844
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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: CYTARABINE, MFR UNK; SYRINGE, MFR UNK
• Patient Age: 57 YR