MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CH-12
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a chemoclave® bag spike with additive port dry spike had particulate matter on the intravenous (iv) tubing drip chamber after spiking a ch-12 bag spike connected to a vincristine bag which was found by the registered nurse (rn) prior to patient use.The tubing was replaced and therapy was resumed.Upon inspection by the oncology pharmacist, it appeared that the spike from the tubing set sheered off a large sliver of plastic from the inner surface of the port.There was no patient harm reported.No additional information is available at this time.This is one of two reports.
Additional Manufacturer Narrative
Dislodged portions of what appear to be the diaphragm of the ch-12 dry spike adapter were observed and confirmed in the drip chamber and in the tubing distal of the mating device drip chamber.When the mating device drip chamber spike was removed from the ch-12 dry spike adapter the diaphragm of the ch-12 dry spike adapter was torn and pieces were missing.This type of particle generation is typical of twisting the mating device spike back ad forth into the ch-12 dry spike adapter thus tearing the diaphragm during use.The dfu states: if utilizing a dry spike adapter: spike set straight into the dry spike until the membrane is punctured and rotate the set with one full turn in one direction.Do not twist back and forth.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY SPIKE
• 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: 16246256
• Report Number: 9617594-2023-00039
• Device Sequence Number: 6523327
• Product Code: ONB
• UDI-Device Identifier: 00840619023713
• UDI-Public: (01)00840619023713(17)270801(10)7917729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

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 Model Number: CH-12
• Device Catalogue Number: CH-12
• Device Lot Number: 7917729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: VINCRISTINE, UNK MFR
• Patient Sex: Unknown