MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE; STOPCOCK, I.V. SET

Catalog Number 011-CH3142

Device Problem Particulates (1451)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The incident involved a 43 cm (17") appx 6.9 ml, trifuse add-on set w/3 clamps (blue, 2 red), dry spike adapter.The reporter stated that after the nurses prepare their lines by attaching the spike to saline, then attaching the iv line, plastic is noted in the iv line chamber when priming with saline.The sets were not reprocessed or re-sterilized prior to use.There was no patient involvement, no delay in therapy, and no one was harmed as a result of the reported event.This is the second of three reports.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint of particulate matter on item 011-ch3142 could not be confirmed by investigation since no 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 for lot#8688075 was reviewed and no non conformities were found that would have led the reported complaint.

• Brand Name: 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE
• 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: 17325610
• MDR Text Key: 319662187
• Report Number: 9617594-2023-00387
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619098476
• UDI-Public: (01)00840619098476(17)270901(10)8688075
• 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: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 8688075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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: SALINE, MFR UNK; VLON72 IV SET, FRESENIUS KABI; VLSP90 IV SET, FRESENIUS KABI; VLST02 IV SET, FRESENIUS KABI; VLTR42 IV SET, FRESENIUS KABI