MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RE; STOPCOCK, I.V. SET

Catalog Number CH3142

Device Problem Particulates (1451)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved a 14" (36 cm) appx 6.9 ml, trifuse add-on set with 3 bag spikes, 3 clamps (blue, 2 red), dry spike adapter.The reporter stated that after nurses prepare their lines by attaching the spike to saline, then attaching the iv line, plastic is noted within iv line chamber.When un-spiking the iv line, plastic is seen in the spike hole at base of the spike with iv line spike intact.The other products used were several iv lines from fresenius kabi fk.The event was noted during priming.No medication was being used with the products.There was no patient involvement, no delay in therapy, and no one was harmed as a result of the reported event.

Manufacturer Narrative

A couple of photos were shared by customer, a small plastic particulate floating inside the drip spike adapter is observed, the source of the particle may come from inside the dry chamber, no additional damage or anomalies were observed in the photos.Complaint of particulate matter can be confirmed based in the photos returned by customer.The probable cause of the excess of plastic inside the dry spike adaptor was due an error during molding process from ensenda's supplier.

Manufacturer Narrative

No assignable cause related to icu medical product manufacturing or design was identified.Reported condition was replicated when using the drip chamber spike provided by the customer and the shape of this drip chamber used to access the icu medical dry spike is considered the most relevant factor to create these particulates.Probable cause of the drip chamber tip got broken inside the dry spike adaptor was due to unintentional bending force applied during use.Corrective actions are in process.

• Brand Name: 14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RE
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17163245
• MDR Text Key: 318042517
• Report Number: 9617594-2023-00251
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619098476
• UDI-Public: (01)00840619098476(17)270601(10)6036651
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082836
• 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,Followup
• Report Date: 05/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CH3142
• Device Lot Number: 6036651
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 09/25/2023; 04/24/2023
• Supplement Dates FDA Received: 09/28/2023; 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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 LINES, FRESENIUS KABI.