MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® VENTED VIAL SPIKE, 20MM; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CH-70S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date and involved a chemoclave® vented vial spike, 20mm.The customer reported leakage which occurred through the filter during the withdrawal of a cytotoxic drug from the vial.The event occurred during preparation (spanning two minutes of use) of an infusion bag.The reported issue was detected prior to patient use.The device was not changed out or replaced with no further problems encountered.Although there was no patient involvement, no serious injury/death, no medical/surgical intervention required, no delay in critical therapy and no adverse operator consequences, there was an unprotected exposure to cytotoxic chemotherapy reported.
Additional Manufacturer Narrative
One used list #ch-70s, chemoclave® vented vial spike, 20mm; lot #5599451 and one (1) used holoxan 1000mg vial were received and visually inspected.As received, fluid was identified within the filter housing.No other damage or anomalies were observed.The vial spike was functionally tested by water infusion.Gross leakage was observed from the filtergaurd vent hole.Further evaluation of the filtergaurd subassembly revealed the filter membrane was missing.The reported complaint can be confirmed.The probable cause of the missing filter membrane and subsequent leakage is due to an error during manual assembly during manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information added to a5 and a6.D9 - date returned to mfg: 5/24/2022.

• Brand Name: CHEMOCLAVE® VENTED VIAL SPIKE, 20MM
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14283125
• Report Number: 9617594-2022-00109
• Device Sequence Number: 4859980
• Product Code: ONB
• UDI-Device Identifier: 00840619070663
• UDI-Public: (01)00840619070663(17)260901(10)5599451
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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 Model Number: CH-70S
• Device Catalogue Number: CH-70S
• Device Lot Number: 5599451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/28/2022
• 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: IFOSFAMIDE (HOLOXAN), MFR UNK; UNSPECIFIED IV BAG, MFR UNK
• Patient Sex: Unknown