MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 16.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 2 GANG 4-W; STOPCOCK, I.V. SET

Catalog Number B90019

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The event occured on an unspecified date and involved a 128" (325 cm) appx 16.5 ml, 15 drop primary set w/2 microclave®, remv 2 gang 4-way clave® stopcock, rotating luer, 2 ext.It was reported that the set had disconnected at a connection point mid procedure.Drainage was found on the bed and floor and discovered the connection had come apart during a surgical procedure.The description provided was that it was the tubing that had come out of the connection; it was not related to the screw on securement of the connection.There was patient involved and no patient harm.

Manufacturer Narrative

The reported complaint of separation was confirmed.An image was provided by the customer showing a damaged clave site.However, the damaged y-clave was not returned for evaluation.Without the return of the y-clave, a probable cause could not be determined.During visual inspection of the sample, the 6" pvc tubing was received separated from the adapter.The adapter was not returned for evaluation.When the end of the tubing was microscopically examined, insufficient solvent coverage was observed.The probable cause of the tubing separation had occurred due to insufficient solvent coverage on the tubing during assembly.

• Brand Name: 128" (325 CM) APPX 16.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 2 GANG 4-W
• 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: l covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18596505
• MDR Text Key: 334844339
• Report Number: 9617594-2024-00062
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B90019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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