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 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Sister samples from the affected lot number are available to be returned for evaluation; however, they have not yet been received.Additional internal contact: (b)(4).

Event Description

The event occurred on an unspecified date and involved a 43 cm (17") appx 6.9 ml, trifuse add-on set w/3 clamps (blue, 2 red), dry spike adapter.The customer reported experienced an issue with the 2, 3 and 4 prong attachment set.During priming and when connected to an iv line, there were small bits of plastic visible in the iv line.When it was disconnected for further inspection, there was a large piece of plastic in the 3 prong attachment tube that was able to be removed.It was confirmed that the spike on the line that was attached to the prongs has remained intact therefore the plastic was not from the line.There was no medication in use at the time of the event.There was no patient involvement and no report of harm.

Manufacturer Narrative

The following items were received for investigation: 2 new list #011-ch3142, 43 cm (17") appx 6.9 ml, trifuse add-on set w/3 clamps (blue, 2 red), dry spike adapter; lot #5970631.As received, there was no contamination or particulate of any kind observed in either sample.No matting device was returned.The customer's complaint was not 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.D9 - date returned to mfg:07-jun-2023.

• 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: 16985974
• MDR Text Key: 315799344
• Report Number: 9617594-2023-00195
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619098476
• UDI-Public: (01)00840619098476(17)270501(10)5970631
• 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
• 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: 05/23/2023
• 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: 5970631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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: UNSPECIFIED IV LINE, MFR UNK.