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 Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.The investigation is not yet complete.
Event or Problem Description
The event involved an oncology kit w/spinning spiros, c-clip, red cap that disconnected from the bd pump set during infusion of vincristine and nelarabine resulting in a leak of medication.The exact location of the disconnection is the male luer of the bd/carefusion set connection to the female luer connection of the spiros.The event occurred before connection to the patient.The medication came into contact with the patient or health care provider.The chemotherapy spill was cleaned per facility protocol.There was no blood loss or bleed back.The spiros was replaced and the drug resumed.There was patient involvement but no report of adverse event.
Additional Manufacturer Narrative
H10: three new list# ch3581, oncology kit w/spinning spiros®, c-clip, red cap (lot# 3396231) and one (1) alaris set were received and visually inspected.No damage or anomalies were seen on the three (3) new spiros devices.No damage or anomalies on the male luer of the alaris set.No c-clip had been attached to the alaris as received.All returned spiros were functionally tested and met product performance specifications.The luers of all the returned devices were measured and found to meet iso standards.No leaks or disconnections occurred during functional testing.Without the return of any used devices, the reported complaint of a disconnection resulting in leakage could not be confirmed or replicated.A device history review (dhr) lot# 3396231 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• 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: 10135643
• Report Number: 9617594-2020-00168
• Device Sequence Number: 17049532
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: (01)00887709079243(17)220101(10)3396231
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 01/01/2022
• Device Catalogue Number: CH3581
• Device Lot Number: 3396231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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: CAREFUSION INFUSION PUMP SET, BECTON DICKINSON MFR; NELARABINE, UNK MFR; TKO CONNECTOR, UNK MFR; VINCRISTINE, UNK MFR