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

Catalog Number 142290490

Device Problems Contamination (1120); Particulates (1451)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

Event Description

The event occurred on an unspecified date and involved a secondary set, secure lock, 34 inch.It was reported that they came across what appears to be a piece of plastic within the secondary set.The device was not used on a patient and there was no harm associated with this event.

Manufacturer Narrative

Photos were returned showing the lot number and the drip chamber with white plastic inside of the drip chamber.Received one (1) used 142290490 secondary set for inspection.A white piece of particulate was observed in the drip chamber.When fluid was flushed through the system the particulate remained in the drip chamber and did not flush down the fluid path.The particulate was submitted to an (fourier transform infrared.) ftir.The closest correlation found was acrylonitrile butadiene styrene (abs) plastic, the material used for the piercing pin.The reported complaint can be confirmed.The probable cause is due to flash during molding during manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: SECONDARY SET, SECURE LOCK, 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18149953
• MDR Text Key: 328297611
• Report Number: 9615050-2023-00640
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006282
• UDI-Public: (01)10887787006282(17)260601(10)13608178
• 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
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142290490
• Device Lot Number: 13608178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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