MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH3581

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint of leaks on item ch3581 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.The device history review (dhr) couldn't be performed due to lot number for this complaint was unknown.Medsun medwatch mandatory report uf/importer report # (b)(4).

Event Description

The event involved an oncology kit w/ spinning spiros, c-clip, red cap where it was reported that the device leaked.Mycophenolate leaked out between distal end of primary tubing and spiros closed system drug-transfer device (cstd).The patient had exposure to medication that leaked out onto his bedding and did not receive full dose of medication.This is a single-use device not reprocessed and reused on a patient.There was patient involvement and unknown harm reported.

• Brand Name: ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, 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: 18757573
• MDR Text Key: 335993658
• Report Number: 9617594-2024-00176
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH3581
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MYCOPHENOLATE, UNK MFR
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 69 KG