MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Not Applicable (3189)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involved.Incident occurred during a demonstration.Waiting on this information expiration date, udi and manufacture date.Product is being returned to 3m (b)(4) for evaluation.The reason this incident was reported is that 3m is aware of leaks at the "y" connector and has reported these types of incidents during patient use.End of report.

Event Description

It was alleged a 3m¿ ranger¿ high flow disposable set leaked within the "y" connector during a product demonstration at a conference.The product was used for a demo presentation when the customer noticed the leak.This product was not being used on a patient nor in a clinical setting.

• Brand Name: 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET
• Type of Device: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NYPRO PRECISION ASSEMBLIES; sor juana ines de la cruz; cd. industrial; tijuana, tijuana baja california 22444 ; MX 22444
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 7092003
• MDR Text Key: 95073023
• Report Number: 2110898-2017-00147
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 24355
• Device Lot Number: HX7665
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other