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 Problem Particulates (1451)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

The incident 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 june 2023.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 two reports.

Manufacturer Narrative

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

Manufacturer Narrative

A used sample #ch3139 connected into a 0.9% sodium chloride 500ml bag and an unknown, extension set w/ drip chamber was returned for evaluation.As received inside of the dry chamber, a small debris was found floating.Inside the dry spike adaptor, it was observed an excess of plastic.The set was tested using a filtration system, and a small plastic debris was found belonging from the spike adaptor.Complaint of particulate matter can be confirmed based in the physical sample returned by customer.The probable cause of the excess of plastic inside the dry spike adaptor was due an error during molding process from manufacturer¿s (ensenada) supplier.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

Manufacturer Narrative

The customer's complaint of particulate matter can be confirmed based in the physical sample returned by customer.No assignable cause related to icu medical product manufacturing or design was identified.Reported condition of the returned device was replicated.The shape of this drip chamber used to access the icu medical dry spike is considered the most relevant factor to create these particulates.The probable cause was that the drip chamber tip got broken inside the dry spike adaptor due to unintentional bending force applied during use.Updated information can be found in g1.D9 date returned to mfg: 08aug2023.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17316462
• MDR Text Key: 318963957
• Report Number: 9617594-2023-00370
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024918
• UDI-Public: (01)00840619024918(17)271201(10)13408928
• 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,Followup
• Report Date: 05/02/2024

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: CH3139
• Device Lot Number: 13408928
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 09/25/2023; 04/04/2024
• Supplement Dates FDA Received: 10/02/2023; 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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