MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60 (152 CM) APPX 1.9 ML, SMALLBORE EXT SET W/MICROCLAVE CLEAR, 0.2 MICRON LOW; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3603
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Investigation is pending.
Event or Problem Description
The event involved a 60¿ (152 cm) appx 1.9 ml, smallbore ext set w/microclave® clear, 0.2 micron low protein binding filter, spiros® w/red cap, clamp that the customer reported an unspecified chemotherapy medication leaking from the filter during patient use.There was patient involvement; however, no report of adverse event.This event captures the first of two incidents.
Additional Manufacturer Narrative
H10: one used list #ch3603, 60¿ (152 cm) appx 1.9 ml, smallbore ext sets w/microclave® clear, 0.2 micron low protein binding filter, spiros® w/red cap, clamp,( lot #unknown), one (1) new list #ch3603, 60¿ (152 cm) appx 1.9 ml, smallbore ext set w/microclave® clear, 0.2 micron low protein binding filter, spiros® w/red cap, clamp, (lot #5012557) and one (1) used bd 0.9% sodium chloride injection, usp 10 ml syringe were received and visually inspected.As received, the 0.2 filter vent material of the used set was slightly wetted out with prior infusate solution.No other damage or anomalies were seen.Each extension set was primed with water at gravity pressure and then leak tested according to product performance specifications.No leaks were observed.The reported complaint could not be replicated or confirmed.The lot history was reviewed and no nonconformities were found that may have contributed to the complaint.

• Brand Name: 60 (152 CM) APPX 1.9 ML, SMALLBORE EXT SET W/MICROCLAVE CLEAR, 0.2 MICRON LOW
• 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: 10931254
• Report Number: 9617594-2020-00518
• Device Sequence Number: 545270
• Product Code: FPA
• UDI-Device Identifier: 00887709081147
• UDI-Public: (01)00887709081147(17)250901(10)5012557
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• 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): 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: 09/01/2025
• Device Catalogue Number: CH3603
• Device Lot Number: 5012557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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: UNSPECIFIED CHEMOTHERAPY