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 first 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 #ch3142 connected into a 0.9% sodium chloride 500ml bag and an unknown, extension set w/ drip chamber was returned for evaluation.As received it was observed in a white debris floating inside the dry chamber.A dry chamber tip was observed broken inside the dry spike adaptor.The samples was tested using a filtration system and no debris was found.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.And the probable cause of the dry chamber tip got broken inside the dry spike adaptor was due to unintentional bending force applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on 8-aug-2023.

Manufacturer Narrative

The complaint investigation was updated and re-summarized as follows: a used sample #ch3142 connected into a 0.9% sodium chloride 500ml bag and an unknown, extension set w/ drip chamber was returned for evaluation.As received, a white debris was identified floating inside the dry chamber.A dry chamber tip was observed to be broken inside the dry spike adaptor.The sample was tested using a filtration system and no debris was found.The 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.The reported condition was replicated when using the drip chamber spike provided by the customer.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 of the drip chamber tip getting broken inside of the dry spike adaptor was due to unintentional bending force applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Updated information can be found in g1 and h6 codes.D3 - manufacturing plant country: mex.

• 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.
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17325369
• MDR Text Key: 319225354
• Report Number: 9617594-2023-00383
• 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 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: 6036651
• 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: 07/01/2022
• 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.