MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. VENTED BAG SPIKE, CLAVE®; STOPCOCK, I.V. SET

Catalog Number	886-CH-14
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded, but the customer sent a video confirming the leak at bag spike/clave bonded connection.Investigation identified that the breakage most likely occurred during the handling and transfer of the set on the cart.The lot review was performed and did not identify any non conformances or issues during manufacturing.
Event or Problem Description
The event involved an allegation of a broken spike that resulted in leaking of chemotherapy drug (evoltra) at the site between white and blue part.There was patient involvement, but no blood loss, no unprotected chemo exposure and no adverse event.

• Brand Name: VENTED BAG SPIKE, CLAVE®
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. IL
• MDR Report Key: 8297412
• Report Number: 9617594-2019-00027
• Device Sequence Number: 2463387
• Product Code: FMG
• UDI-Device Identifier: 00840619084592
• UDI-Public: (01)00840619084592(17)230201(10)3624275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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 Catalogue Number: 886-CH-14
• Device Lot Number: 3624275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/01/2019
• 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: EVOLTRA