MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1423028

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The event involved a secondary set, secure lock, with iv set hanger, 34 inch in which the customer reported that, on an unspecified date, the product was taken out of individual packaging to put the secondary set on an iv bag to prime before mixing chemotherapy drug, it was noted that secondary set had mold on the interior.There was no patient involved and no harm reported as a consequence of this event.

Manufacturer Narrative

The actual device was not returned for evaluation.Two photos were received showing the secondary set inside a bag.Received one photo showing the lot information of the packaging.No particulates or anomalies can be observed.The complaint of particulate cannot be confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A device history review was performed and no non conformities were found that would have led to the reported complaint.

• Brand Name: SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14601457
• MDR Text Key: 293450024
• Report Number: 9615050-2022-00110
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006268
• UDI-Public: (01)10887787006268(17)230501(10)4766594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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: 05/01/2023
• Device Model Number: 1423028
• Device Catalogue Number: 142300490
• Device Lot Number: 4766594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1