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 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

No patient injury nor patient information provided after multiple attempts to obtain information.Waiting on receipt of expiration date, udi and manufacture date.Will be submitted under supplement.A follow-up for additional information is being made.Not sure product initial report came from hospital.Product was not returned to 3m (b)(6) for evaluation.No information was provided as to the where the leak occurred and if the leak occurred during patient use.Three (3)m implemented a new dehp free material to enhance the material properties on all 3m ranger(tm) fluid warming disposable products in 2013.Subsequent to this change 3m received a higher trend of complaints applicable to leaks within selected areas of the disposable tubing connections.Three (3)m implemented a solvent improvement process in late 2015 to address this type of event.This improvement was to the solvent bond process to reduced leaks on all of the following areas; y-connector, drip chamber, bubble trap and tube fitting which are part of the high flow disposable set.The change was implemented to increase strength and to minimize leaks.Three (3)m continues to monitor their complaints to confirm the effectiveness of the changes made.End of report.

Event Description

A distributor alleged that a 3m¿ ranger¿ high flow disposable set leaked.No injury was alleged in the initial report and no specific patient information was provided.No information as to the type of fluid or conditions were provided.Three attempts have been made to obtain additional information.

Manufacturer Narrative

Expiration date and manufacturing date provided.Udi was not implemented at the time this product was produced nor required.

• 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: 7169678
• MDR Text Key: 96727859
• Report Number: 2110898-2018-00003
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 24355
• Device Lot Number: HX7753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2016
• 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