MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20ML SYRINGE W/SPINNING SPIROS®, RED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.However, the customer provided a photo for evaluation.The evaluation has not yet been completed.
Event or Problem Description
The incident involved a 20ml syringe w/spinning spiros®, red cap.It was stated in the report that the doxorubicin syringe spilled onto the chemo pads at the end of the iv push.The spiros was attached correctly but somehow drug leaked out.No drug got on the patient or nurse.The patient was able to receive the majority of drug and no need to remake.On completion of iv push, the nurse noticed red drops of chemo on the chucks pad.The patient had received the full dose, but chemo was spilling out from the spiros cap.The cap filled with chemo, which typically does not happen.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
One (1) photo was shared by the customer, where the item #ch2020 is observed to be fully connected into a syringe.A leak around and inside the spiro is observed.No additional damage was observed on the photo.The complaint of leaks can be confirmed based on the photo provided by customer.However, since no product sample was received for investigation a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history review for lot#5589540 was reviewed and no non conformities were found that would have led the reported condition on the complaint.

• Brand Name: 20ML SYRINGE W/SPINNING SPIROS®, RED CAP
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 18113254
• Report Number: 9617594-2023-00976
• Device Sequence Number: 20845890
• Product Code: ONB
• UDI-Device Identifier: 00840619081201
• UDI-Public: (01)00840619081201(17)260901(10)5589540
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2026
• Device Catalogue Number: CH2020
• Device Lot Number: 5589540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DOXORUBICIN, MFR UNK
• Patient Sex: Unknown