MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID 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 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involved and no reported injury.Lot number was provided.Will obtain expiration date and manufacture date and provide under a follow-up report to this initial report.Product used was not returned to determine cause of reported event.

Event Description

A nurse reported that a 3m ranger(tm) high flow blood/fluid disposable set was attached through the set's iv spikes to intravenous bags for fluid delivery during a trauma situation.At least one of the bags contained blood.The intravenous bags were placed in a 3m pressure infusor.No other pumps or pressure devices were being used.During blood delivery the tubing allegedly separated from the iv spike in the ranger tubing.Blood leaked, exposing a health care provider to blood.No injury was alleged to the health care provider or the patient although there was a delay in patient care while the issue was resolved.

Manufacturer Narrative

This follow-up report is providing the expiration date and manufacturing date applicable to the lot number provided under the initial report.

• Brand Name: 3M RANGER(TM) HIGH FLOW BLOOD/FLUID 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: 6571117
• MDR Text Key: 75310849
• Report Number: 2110898-2017-00079
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 24355
• Device Lot Number: HX7803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2016
• 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