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

Catalog Number	CH-70
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that a chemoclave® vented vial spike, 13mm with list number ch-72 and lot number 13774808.The reporter stated that "reconstituting a pembrolizumab, when turned upside down to put pembro liquid into syringe the pembro spike leaked all over staff members hand.".It was unknown if the sample was available for investigation.The status of the product at the time of the event was unknown.There was patient involvement, but no harm was noted.
Additional Manufacturer Narrative
Additional/updated information can be found in b5, d8, e3.Corrected information can be found in h6, component code.
Event or Problem Description
The customer provided additional information as follows: while making up immunotherapy and drawing up the treatment in a closed system via a syringe, the chemo clave universal vented spike shot the immunotherapy out of a crack in the side of the equipment that was discovered to be defective.This went on the preparer's gloves and a puddle of immunotherapy was present in the blue clinical tray.The product was stored in room temperature in the storeroom inside of a cupboard.

• Brand Name: CHEMOCLAVE® UNIVERSAL VENTED VIAL 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20478440
• Report Number: 9617594-2024-01470
• Device Sequence Number: 8275710
• Product Code: ONB
• UDI-Device Identifier: 00840619025854
• UDI-Public: 00840619025854
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2024

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 Catalogue Number: CH-70
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PEMBROLIZUMAB, UNK MFR.
• Patient Sex: Unknown