MAUDE Adverse Event Report: 72-IN NON-DEHP MICROBOREE EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME2059
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 72-in non-dehp microboree ext sets were blocked/occluded, and medicine had to be manually pushed through the syringe pump.The following information was provided by the initial reporter: "i have some syringe pump tubing (bd maxguard extension set refme2059 with an attached nexus tko needleless connector) that wouldn¿t infuse last night when the nurse used an alaris syringe pump.She was able to manually push the medication through the syringe pump tubing, but the pump would not deliver the medication.".
Additional Manufacturer Narrative
Investigation summary: 2 samples were returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sets were manually primed with saline by attaching a 10 ml bd syringe to the female luer.The set and syringe was attached to bd syringe pump dhcu-0008 module dchu-0017 for 1ml/hr for 15 minutes.An occlusion was not observed.The customer complaint that the syringe pump tubing would not infuse could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 3 72-in non-dehp microboree ext sets were blocked/occluded, and medicine had to be manually pushed through the syringe pump.The following information was provided by the initial reporter: "i have some syringe pump tubing (bd maxguard extension set refme2059 with an attached nexus tko needleless connector) that wouldn¿t infuse last night when the nurse used an alaris syringe pump.She was able to manually push the medication through the syringe pump tubing, but the pump would not deliver the medication.".

• Brand Name: 72-IN NON-DEHP MICROBOREE EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12208162
• Report Number: 9616066-2021-51614
• Device Sequence Number: 4868912
• Product Code: FPA
• UDI-Device Identifier: 50885403236271
• UDI-Public: 50885403236271
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: ME2059
• Device Catalogue Number: ME2059
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1