MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/SPIROS®, RED CAP, BAG SPIKE W/CLAVE® ADDITIVE PORT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3397
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is pending.
Event or Problem Description
The customer reported that an oncology kit w/spiros®, red cap, bag spike w/clave® additive port leaked chemotherapy during priming.There was no patient involvement, no adverse event and no delay in critical therapy.
Additional Manufacturer Narrative
Additional information in g1 - contact office first and last name.H10: received four used ch3397 and five new ch3397 devices.The leakage was not replicated at gravity pressure but at much higher pressures.The leakage occurred at the attachment between the ch3397 tubing and the drip chamber spike of the bd alaris sets.No other leakages were found on the sets.The reported product problem for leakage was confirmed.The probable cause for the leakage found was due to the ch3397 tubing and the bd alaris drip chamber spikes were not attached all the way flush together during use.A lot was reviewed with no issues noted.

• Brand Name: ONCOLOGY KIT W/SPIROS®, RED CAP, BAG SPIKE W/CLAVE® ADDITIVE PORT
• 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: 8851844
• Report Number: 9617594-2019-00254
• Device Sequence Number: 16225498
• Product Code: FPA
• UDI-Device Identifier: 00840619073671
• UDI-Public: (01)00840619073671(17)240601(10)4124322
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 06/01/2024
• Device Catalogue Number: CH3397
• Device Lot Number: 4124322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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: UNKNOWN CHEMOTHERAPY.