MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALL BORE PRESSURE TUBING EXTENSION SET, RED NEEDLELESS VALVE STOPCOCK; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 46400-27

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The event involved a 4" small bore pressure tubing extension set, red needleless valve stopcock and occurred on an unspecified date.It was reported that the iv tubing is leaking thus it was changed.There was unknown patient involvement and unknown human harmed.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Section e additional contact: (b)(6).

Manufacturer Narrative

1 used sample was returned along with 3 new samples provided by the end user.The reported complaint of separation was confirmed on the returned used set and not confirmed on the new sets.Used set: during visual inspection, the 4" pressure tubing was received separated from the female luer on the used set.The end of the tubing was observed to be tacky on the used set.The probable cause of the pressure tubing being tacky is due to the uv adhesive on the tubing not being fully cured during assembly process at ensenada.New sets: no visual anomalies were observed on the new sets returned.The returned sets were primed and pressure leak tested, no leaks were observed.The products had performed per the specifications.The possible lot numbers were reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 4" SMALL BORE PRESSURE TUBING EXTENSION SET, RED NEEDLELESS VALVE STOPCOCK
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18636967
• MDR Text Key: 334845731
• Report Number: 9617594-2024-00087
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K932141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46400-27
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• 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