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 011-CH3142

Device Problem Particulates (1451)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

Sister samples from the affected lot number are available to be returned for evaluation; however, they have not yet been received.

Event Description

The event involved a 43 cm (17") appx 6.9 ml, trifuse add-on set w/3 clamps (blue, 2 red), dry spike adapter where it was reported that after the nurses prepared their lines by attaching the ch3142 spike to saline, then attaching the iv-line, when priming saline, pieces of plastic was noted within iv-line chamber.When un-spiking the iv-line, plastic noted to be seen in the spike hole at base of ch3142 spike with the iv-line spike intact.The other product used were several iv lines with list numbers: vlsp90, vlon72, vltr42 and vlst02 manufactured by fresenius krabi.There was no patient involvement or patient harm.

Manufacturer Narrative

The complaint of particulate matter on item (b)(4) cannot be confirmed by investigation.Since no evidence of plastic noted in the spike hole at base of the spike, due to product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history report (dhr) lot# 6036651 was reviewed and no non conformities were found that would have led the reported condition on the complaint.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17131134
• MDR Text Key: 317252119
• Report Number: 9617594-2023-00243
• 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
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: 011-CH3142
• Device Lot Number: 6036651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2022
• 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-LINE LIST #VLON72, FRESENIUS KRABI MFR.; IV-LINE LIST #VLSP90, FRESENIUS KRABI MFR.; IV-LINE LIST #VLST02, FRESENIUS KRABI MFR.; IV-LINE LIST #VLTR42, FRESENIUS KRABI MFR.; SALINE, MFR UNK.