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 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

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 on (b)(6) 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 first of three reports.

Manufacturer Narrative

Device returned to manufacturer on 8-aug-2023.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.No debris floating inside the drip chamber was observed.Inside the dry spike adaptor the presence of plastic (flash) was observed.The sample was tested using a filtration system, and in the filter a small plastic debris were found belonging from the dry 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 ensenada's supplier.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

Manufacturer Narrative

Updated investigation received: complaint of particulate matter can be confirmed based in the physical samples returned by customer.No assignable cause related to icu medical product manufacturing or design was identified.Reported condition was replicated when using the drip chamber spike provided by the customer and the shape of this drip chamber used to access the icu medical dry spike is considered the most relevant factor to create these particulates.Probable cause of the drip chamber tip got broken inside the dry spike adaptor was due to unintentional bending force applied during use.Corrective actions are in process.

• 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: 17305209
• MDR Text Key: 319187193
• Report Number: 9617594-2023-00350
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024918
• UDI-Public: (01)00840619024918(17)261101(10)5675428
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• 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: 5675428
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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
• Treatment: SALINE, MFR UNK; VLON72 IV SET, FRESENIUS KABI; VLSP90 IV SET, FRESENIUS KABI; VLST02 IV SET, FRESENIUS KABI; VLTR42 IV SET, FRESENIUS KABI