MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),; STOPCOCK, I.V. SET

Catalog Number CH3139

Device Problems Contamination (1120); Particulates (1451)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

The event involved a 15" (38 cm) appx 4.7 ml, bifuse add-on set w/2 bag spikes, 2 clamps (red, blue), plug adapter on an unknown date in (b)(6) 2023.The reporter stated that when they connect the set onto an iv line there are small bits of plastic visible in the iv line.When the set was disconnected for further inspection, there was a large piece of plastic in the 3-prong attachment tube that the reporter was able to get out.The spike on the line which was attached to the prongs remained intact; therefore the plastic is not from the spike.The event occurred during priming.There was no patient involvement.This is the second of five reports.

Manufacturer Narrative

The affected device is not available for investigation.Companion samples have been requested to be returned for evaluation; however, they have not yet been received.

Manufacturer Narrative

D9: sample was returned for evaluation on 07-jun-2023.Two (2) new samples item #ch3139 were received.Once the samples were opened and inspected there was not observed any kind of contamination / particulates inside or outside the package.No mating device was returned.The customer's complaint of foreign matter cannot be confirmed based on the physical sample evaluation.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 15" (38 CM) APPX 4.7 ML, BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE),
• 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: 16992503
• MDR Text Key: 316251654
• Report Number: 9617594-2023-00202
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024918
• UDI-Public: (01)00840619024918(17)261001(10)5665011
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964435
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH3139
• Device Lot Number: 5665011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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