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

Catalog Number CH2000S-C

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The incident involved a spinning spiros® closed male luer, red cap.It was stated in the report that the patient went to the bathroom in the morning and when finished, she noticed that her chemotherapy tubing was disconnected from her peripherally inserted central catheter (picc) line.The nurse was notified right away and the patient was standing in the room holding her iv tubing with chemo disconnected from the spiros connection, while the spiros connection was still hooked up with the picc line.It was noted to have a small spill in the form of drops on the floor of her room.The spiros cap was attached to the primary iv line attached to a normal saline 1l bag which had secondary chemo (cytarabine) infusing at the time the leak was noted.There was a delay in therapy as the chemo infusion had to be stopped and spill cleaned before continuing treatment.There were no obvious defects noted on the tubing set like crack or breaks, however, there was an unprotected exposure to the patient.

Manufacturer Narrative

One (1) used sample of item #ch2000s-c was returned for evaluation, as received a dry ns and cytarabine solution inside the spiros was observed.The spinning mechanism didn¿t rotate.The activation torque failed the specification because the dry solution inside the spiros jammed the mechanism.However, due to no mating devices being returned for evaluation, it was not possible to verify or confirm anomalies that might lead the disconnection and eventually leaks.Complaint of leaks can be confirmed, based on the dry solution inside the spiro.However, without the returned of mating device, how, when or where the solution got inside the spiros cannot be determined.A lot history review was performed and no relevant commodities, discrepancy or anomalies were identified that might lead the condition reported by customer.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17939817
• MDR Text Key: 325737827
• Report Number: 9617594-2023-00832
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)271201(10)13490092
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082806
• 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,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 13490092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• 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: CYTARABINE, MFR UNK.; NORMAL SALINE, MFR UNK.; PICC LINE, MFR UNK.