MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® UNIVERSAL VENTED VIAL SPIKE; VIAL ADAPTER

Model Number	CH-70
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return to the manufacturer; it has not been received.
Event or Problem Description
The date of the event is unknown.The product involved is an icu medical chemoclave universal vented vial spike.It was reported that at the time of the insertion of the spike, drops from a leakage are found inside the vial containing an anticancer drug.
Additional Manufacturer Narrative
Updated information can be found in g1.H10: no product sample was returned and no photographs or videos were provided for investigation.Therefore a comprehensive failure investigation was unable to be performed and a probable cause cannot be identified based on the information provided.The dhr lot number review did not identify any non conformances that would have contributed to the reported complaint.

• Brand Name: CHEMOCLAVE® UNIVERSAL VENTED VIAL SPIKE
• Common Device Name: VIAL ADAPTER
• 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: 8851762
• Report Number: 9617594-2019-00253
• Device Sequence Number: 13857421
• Product Code: ONB
• UDI-Device Identifier: 00840619025854
• UDI-Public: (01)00840619025854(17)230201(10)3623776
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: 02/01/2023
• Device Model Number: CH-70
• Device Catalogue Number: CH-70
• Device Lot Number: 3623776
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1