MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3581
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and is not available for evaluation.If additional information is received, a supplemental report will be submitted.
Event or Problem Description
The customer reported via user facility mandatory medwatch (b)(4) that while chemotherapy was being primed in the medication room with spiros, the spiros "clicked" onto the tubing but the c-clip was having issues clicking.When attaching the spiros to the chemotherapy, it started to back prime and leaked out of spiros.Chemotherapy was returned to the pharmacy.There was patient involvement that resulted in delay of therapy.This is report 1 of 5.

• Brand Name: ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP
• 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: 10972065
• Report Number: 9617594-2020-00526
• Device Sequence Number: 3186396
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: (01)00887709079243(17)250801(10)4962268
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2020

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: 08/01/2025
• Device Catalogue Number: CH3581
• Device Lot Number: 4962268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR