MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EMPTY LIFECARE CONTAINER 100 ML SIZE; CONTAINER, I.V.

Catalog Number	079510471
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint on an unknown date involving a empty lifecare container 100ml size experienced foreign matter.The reporter stated that bag was found to have particulate matter inside.The reporter added that they noticed the plastic particulate matter inside the bag once the bag was spiked and the diluent and/or drug were added.The particulate matter floated in the solution.No fluid inside the container since it's an empty bag.The event occurred when preparing an infusion for a patient.There was no patient involvement, no adverse event and no delay in therapy.Vyanzon (b)(6) 2024 update: icu medical received a medwatch uf/importer report #mw515880.Additional event information obtained from ufmw: the suspect medical device has a common device name of container, i.V.
Additional Manufacturer Narrative
Medwatch received mw5158801.E1 phone number - not provided - used phone number associated with the hospital the device has been received, but an investigation is not yet completed.When complete, then a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Received three (3) used list# 079510471 empty lifecare container 100 ml size.As received no damage or anomalies were observed.Replicating clinical use water was added through the port of each set.No particle matter was observed in any of the samples.The complaint of particulate inside the bag cannot be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EMPTY LIFECARE CONTAINER 100 ML SIZE
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20251449
• Report Number: 9615050-2024-00685
• Device Sequence Number: 8163222
• Product Code: KPE
• UDI-Device Identifier: 10887787006831
• UDI-Public: 10887787006831
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K771228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 10/01/2026
• Device Catalogue Number: 079510471
• Device Lot Number: 13763298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED SPIKE, MFR UNK
• Patient Sex: Unknown