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

It was reported that a 14" (36 cm) appx 6.9 ml, trifuse add-on set w/3 bag spikes, 3 clamps (blue, 2 red), dry spike adapter "after nurses prepare their lines by attaching ch3142 spike to saline, then attaching intravenous (iv) line, when priming saline, plastic is noted within iv line chamber.When un-spiking the iv line, plastic was noted to be seen in the spike hole at the base of the spike.With iv line spike intact.There was no medication being used with this product.The product is not contaminated or contains a biohazard or chemotherapeutic agent.That the event occurred during priming.Nobody was harmed as a result of the reported event.

Manufacturer Narrative

A couple of photos were shared by the customer, in all of them a small plastic particulate floating inside the drip chamber was observed, and no additional damage or anomaly was observed in the photos.One (1) used sample #011-ch3142 connected into a 0.9% sodium chloride 500ml bag and an unknown, extension set w/ drip chamber were returned for evaluation, as received it was observed inside the dry spike adaptor a flash condition (excess of plastic).The set was tested using a filtration system to filter the fluid and no debris was observed.However, inside the drip chamber, a small white particulate was floating.Complaints of particulate matter can be confirmed based on the photos and the physical sample returned by the customer.The probable cause of the excess of plastic inside the dry spike adaptor was an error during the molding process from ensenada's supplier.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.Additional information d9: product received 8/8/2023g1: reed covert.

• 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: 17209800
• MDR Text Key: 317941186
• Report Number: 9617594-2023-00273
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024949
• UDI-Public: (01)00840619024949(17)270301(10)5870799
• 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
• Report Date: 05/31/2023

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: 5870799
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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: VLON72, UKN MFR; VLSP90, UNK MFR; VLST02 UKN MFR; VLTR42, UNK MFR