MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problem Fracture (1260)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however, has not been received yet.E1 initial reporter phone number: (b)(6).

Event Description

The event occurred on an unspecified date and involved an unspecified tubing set.The report stated that they had a broken tubing, the male end fractured.There was unknown patient involvement and unknown harm.

Manufacturer Narrative

Received one used list #unknown primary plum set for inspection.The male luer was broken from the secure lock.The broken male luer tip was not returned for inspection.The shape of the deformation was angled where one sided is higher than the other, typical of a bend break.There was stress whitening on one side and beach marks observed on the opposite higher side.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.Device returned to manufacturer on 12/12/2023.

• Brand Name: UNSPECIFIED TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18414467
• MDR Text Key: 331583065
• Report Number: 9617594-2023-01208
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 02/15/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/15/2024
• 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