MAUDE Adverse Event Report: 3M COMPANY 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 24370

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to 3m for analysis.Upon review of the photos, problem description and sample, a leur leak was verified at the connection of the primary set and the patient line tubing.Visual inspection of sample showed a pinhole in the female luer that is attributed to the molding process.A review of the batch record found no deviations that could have caused or contributed to the reported malfunction.This is an isolated incident for leur leaks in high flow sets.3m will continue to monitor.

Event Description

A user facility reported during use 3m¿ ranger¿ blood/fluid warming high flow set leak whole blood at the leur connection.The customer observed a crack in the inlet terminal thread/inlet side of the roller clamp, from which fluid leaked.No injuries or medical interventions were required due to the alleged malfunction.

• Brand Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NPA DE MEXICO S. DE R.L. DE C.V.; sor juana ines de la cruz #201; 50 interior 5, cd. industrial; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 18902349
• MDR Text Key: 337636976
• Report Number: 2110898-2024-00012
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 10707387792685
• UDI-Public: 10707387792685
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24370
• Device Catalogue Number: 24370
• Device Lot Number: HM9015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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