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

Catalog Number 142300490

Device Problem Particulates (1451)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation-it has not been received.(b)(6).

Event Description

The event occurred on an unknown day in (b)(6) of 2023 involving a secondary set, secure lock, with iv set hanger, 34 inch.The reporter stated that they have examined the sets, and have excluded with the customer the possibility of these particles coming from the iv saline bag that they are using to prime the sets, or any other factors not related to the secondary set.A video was provided showing that it seems to be plastic particles within the drip chamber.The status of the product at time of event was during preparation in the pharmacy.There was no hole, cut, tears or any defect noted.The product stored both in warehouse and the customer storage room with room temperature (15c-25c).The problem was noticed during saline flush before chemotherapy preparation.There was no patient involvement and no patient harm noted.

Manufacturer Narrative

D9 - date returned to mfg on 12/18/2023.Two videos were provided showing white unknown particulates floating inside the drip chamber.As received white unknown particulates ranging in size to be floating inside the drip chamber on 18 of the received samples.The used sets were flushed out and collected in a filtration system.Particulates were found on the filter paper of a few samples.The particulates collected underwent an ftir analysis.The results of the analysis did not indicate a correlation between the particulates and the product in question.The closest correlation found was to natural rubber (latex) at 82.88 percent.Natural rubber is not found in our secondary set assembly.The complaint of particulate inside the fluid path can be confirmed on the received used 142300490 secondary sets.The probable source of the particulates is unknown; however, it is unlikely to have come from icu medical's secondary set assembly as none of its components consist of natural rubber (latex).The lot history was reviewed and no nonconformities were identified that may have contributed 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17961008
• MDR Text Key: 326471659
• Report Number: 9615050-2023-00552
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787006268
• UDI-Public: (01)10887787006268(17)250301(10)5785978
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K142367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142300490
• Device Lot Number: 5785978
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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
• Treatment: IV SALINE BAG, MFR UNK