MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140013190

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device was discarded and is not available for testing.

Event Description

During unpacking, the customer noted a 1cm black piece of plastic inside the tubing.There was no patient involved and no one was harmed.

Manufacturer Narrative

No list #140013190 product samples or videos were returned for investigation.An image was returned showing a discoloration or object within or on the tubing of a plum set.It is not clear from the image what the nature of the object is, or whether it is inside, outside, or embedded in the tubing.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.The reported complaint can be confirmed.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9321821
• MDR Text Key: 167021345
• Report Number: 9615050-2019-00455
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Public: (01)(17)220201(10)3905319
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• 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: 10/25/2019

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 Expiration Date: 02/01/2022
• Device Catalogue Number: 140013190
• Device Lot Number: 3905319
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1