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  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.Possible lot numbers: 4988264 manufacturing date 9/1/2020 device expiration: 09/01/2023.5094506 manufacturing date 12/1/2020 device expiration: 11/01/2023.4943606 manufacturing date 7/1/2020 device expiration: 7/01/2023.

Event Description

It was reported that, on an unknown date, a 4" small bore pressure tubing extension set, red needleless valve stopcock broke during use on the patient.It was reported that the arterial line setup snapped and broke at the level of the transducer when repositioning the patient in bed.Risk of bleeding and contamination was noted thus entire arterial line set-up was changed.There was no patient harm reported.

Manufacturer Narrative

The reported complaint of separation was confirmed.During visual inspection, the 4" pressure tubing was received and separated from the female luer.The end of the tubing was observed to be tacky.The separation of the bond was due to the pressure tubing being tacky.The probable cause of the pressure tubing being tacky is due to the ultraviolet (uv) adhesive on the tubing not being fully cured during the assembly process.The possible lot numbers were reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 2/20/2024.

• 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: 18637122
• MDR Text Key: 334568330
• Report Number: 9617594-2024-00089
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2024

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: 46400-27
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 02/03/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/21/2024
• 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