MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE VENTED VIAL SPIKE, 13MM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH-72
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Missing (2306)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.
Event or Problem Description
The event involved a chemoclave® vented vial spike, 13mm that was missing the filter on the device, and this defect was noted once the bottle is pierced to withdraw the dose.It was reported that the missing filter generated a flow at the filter location which lead to an unprotected chemotherapy exposure and also the loss of the content of the bottle during drug preparation.There was no patient involvement or delay in therapy as the issue was detected prior to patient use.The device was replaced with no further problem encountered.Although unspecified negative clinical consequences on the operator were reported, there was no report of harm or adverse event.
Additional Manufacturer Narrative
One used chemoclave¿ vented vial spike, 13mm and one used vial of bortezomib eg solution injectable 2.5 mg/ml, lot# ok111m0 was received.A photo was provided that showed a chemoclave vented vial spike inside a polybag with the filter vent missing.It was confirmed with the 2um ptfe filter membrane (filter vent) was missing from the returned chemoclave¿ vented vial spike, 13mm.Visual inspection of the filter vent interface with the ultrasonic ring did not show any evidence of a weld that would have secured a filter vent.The probable cause of the missing filter vent is an assembly error during manufacturing.The device history record (dhr) and relevant commodities were reviewed.No non-conformances were found that would have contributed to the reported complaint.D9 - date returned to mfg: 18-may-2021.Additional information can also be found in section h6 - adverse event problem, component code.
Additional Manufacturer Narrative
Additional information can be found in b5 and d10.
Event or Problem Description
Additional information was received.There was a flow of cmr drug (carcinogenic, mutagenic and toxic to reproduction substances) on the gloves.There were no injuries for a patient or operator and no need for medical intervention.There was a spill of dangerous product, cleaned as per protocol, however no specific kit was reported to be used.The operator was protected with proper ppe (gloves and tyvek protection equipment).There were no unprotected exposures (dermal or other kind of exposure).

• Brand Name: CHEMOCLAVE VENTED VIAL SPIKE, 13MM
• Common Device Name: 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
• MDR Report Key: 11665007
• Report Number: 9617594-2021-00105
• Device Sequence Number: 11508277
• Product Code: FPA
• UDI-Device Identifier: 00840619053192
• UDI-Public: (01)00840619053192(17)250901(10)4998195
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2021

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: 09/01/2025
• Device Catalogue Number: CH-72
• Device Lot Number: 4998195
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 06/10/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/23/2021; 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BORTEZOMIB, MFR UNK.; UNSPEC CHEMOTHERAPY, MFR UNK.