MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20" QUADFUSE ADD-ON SET W/4 BAG SPIKES, 4 CLAMPS (BLUE, 3 RED), PLUG ADAPTER; STOPCOCK, I.V. SET

Catalog Number CH3134

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Received a couple of photos were shared by customer where is observed a small white contamination in a used sample.Received two new samples item #ch3134, any kind of contaminations / particulates were observed inside the samples.Complaint of particulate matter can be confirmed based in the photo shared by customer.One image showed white particulate that appears to have come from the inside of the dry spike adaptor.Another image showed the inside of the dry spike adaptor with what appears to be skived plastic due to the insertion of a bag spike.Without the used physical sample and mating devices not returned, the probable cause of the particulate cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

Event Description

The event occurred on an unknown date involving a 20" quadfuse add-on set w/4 bag spikes, 4 clamps (blue, 3 red), plug adapter where the reporter had an issue with the 2, 3 and 4 prong attachment sets.When connected onto an iv line there were small bits of plastic visible in the iv line.When disconnected for further inspection, there was a large piece of plastic in the 3 prong attachment tube that they were able to remove.They confirmed that the spike on the line which was attached to the prongs had remained intact; therefore, the plastic is not from the line.The event occurred during priming with iv giving set as mating device involved.There was no patient involvement, unknown delay in therapy, and no adverse event.This is the fourth of five events.

• Brand Name: 20" QUADFUSE ADD-ON SET W/4 BAG SPIKES, 4 CLAMPS (BLUE, 3 RED), PLUG ADAPTER
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17131087
• MDR Text Key: 317572678
• Report Number: 9617594-2023-00241
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619024864
• UDI-Public: (01)00840619024864(17)270601(10)6011305
• 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
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH3134
• Device Lot Number: 6011305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2022
• 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: IV LINE, MFR UNK