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	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples were received.The investigation is still pending.
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 event occurred 9 minutes into the infusion.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 medication came into contact with the patient or health care provided.The spill was cleaned per facility protocol.The spiros was replaced, and the drug resumed.
Additional Manufacturer Narrative
Eight (8) new list# ch3581, oncology kit w/spinning spiros®, c-clip, red cap.Lot# 4711975 and one (1) new bd alaris pump infusion set, ref # 2420-0007, lot# 20033329 were received for evaluation.As received, no damage or anomalies were identified on any of the returned samples.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 for lot# 4711975 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: 10135650
• Report Number: 9617594-2020-00169
• Device Sequence Number: 14358113
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: (01)00887709079243(17)250101(10)4711975
• 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 Health Care Professional
• 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: 01/01/2025
• Device Catalogue Number: CH3581
• Device Lot Number: 4711975
• 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: 06/11/2020
• 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: BD/CAREFUSION PUMP SET; NELARABINE, UNK MFG; VINCRISTINE, MFR UNK