MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Model Number B4018

Device Problems Connection Problem (2900); Material Split, Cut or Torn (4008)

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

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The event involved a 4-way high flow stopcock w/ rotating luer which was used to infuse fentanyl versed and precedex drips to a critically ill child.The connection between 2 of the stopcocks was found to be split in half and the patient did not receive the infusion for about one hour.There was patient involvement and a delay in therapy, however, there was no patient harm reported as a consequence of this event.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The dhr was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER
• 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
• MDR Report Key: 11748333
• MDR Text Key: 256714396
• Report Number: 9617594-2021-00142
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)251201(10)5119723
• Combination Product (y/n): N
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B4018
• Device Catalogue Number: B4018
• Device Lot Number: 5119723
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FENTANYL, MFR UNK.; PRECEDEX, MFR UNK.