MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 206680490

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without a return of the device a probable cause cannot be determined.

Event Description

The event occurred on an unknown date.The event involved a extension set, 17 inch, 0.2 micron filter, clave ¿ y-site, secure lock that the customer reported leaking during chemotherapy infusion and is the 4 - 5 reoccurring incident and would go back as many as 5- 6 months.Each time the filter cracks or leaks the patient and anyone interacting with that patient is either exposed to chemotherapy or at risk of exposure as the chemotherapy is no longer contained within the closed system.There was patient involvement, however, no report of harm.

Manufacturer Narrative

No product sample was returned for investigation.There was one black and white photo received.The quality of the photo is poor.It is unknown by the picture if the set is leaking or not.Without the return of the product a definitive confirmation and probable cause cannot be determined.The device history review (dhr) could not be reviewed due to the unknown lot number.

• Brand Name: EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9531671
• MDR Text Key: 178617924
• Report Number: 9615050-2019-00479
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: K151969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 206680490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ETOPOSIDE, UNK MFR