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 Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The complaint/event occurred on an unspecified date and involved a 4" small bore pressure tubing extension set, red needleless valve stopcock.It was reported that during retaping of an endotracheal tube (ett,), the short extension of the arterial broke, and there was an estimated blood loss (debl) of 2-3 ml.The arterial canula was clamped in seconds thus the set-up was changed.There was no report of human harm associated with this complaint/event.

Manufacturer Narrative

The following items were provided by the customer for complaint investigation: one used partial list#: 46400-27, 4" small bore pressure tubing extension set, red needleless valve stopcock; one used list#: unknown, transpac set; one (1) used.List#:unknown, 50 ml bd syringe.The reported complaint of separation was confirmed on the returned set.During visual inspection, the 4" pressure tubing was observed to be separated from the female luer.The separated pressure tubing was not received for evaluation.Without the return of the separated pressure tubing, a probable cause could not be identified.The device history record was not reviewed as the lot number in question is unknown.D9: date returned to mfg: 20feb20204.

• 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: 18628480
• MDR Text Key: 334389838
• Report Number: 9617594-2024-00080
• 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: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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: 04/05/2024
• 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
• Treatment: ENDOTRACHEAL TUBE (ETT), MFR UNK.; UNSPECIFIED ARTERIAL LINE, MFR UNK.