MAUDE Adverse Event Report: 60 IN ULTRA MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME2017
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"unknown manufacturer: (b)(4).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.".
Event or Problem Description
It was reported that a 60 in ultra minibore extension set was found to be damaged.The following was reported by the initial reporter: "student rn was screwing flush onto med line tubing per protocol and tubing cracked at hub.Cracked line med was saved and placed in leadership office and new med line was created.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-15.H6: investigation summary a complaint of a set breaking at the hub was received from the customer.One sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.Cracks were seen all around hub, and a piece of the hub had almost broken off.A device history record review could not be performed on model me2017 because a lot number was not provided by the customer.The root cause was identified as internal stresses created in luer during manufacturing process that make it more susceptible to chemical/mechanical attacks.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that a 60 in ultra minibore extension set was found to be damaged.The following was reported by the initial reporter: "student rn was screwing flush onto med line tubing per protocol and tubing cracked at hub.Cracked line med was saved and placed in leadership office and new med line was created.".

• Brand Name: 60 IN ULTRA MINIBORE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12089719
• Report Number: 2243072-2021-01787
• Device Sequence Number: 11953429
• Product Code: FPA
• UDI-Device Identifier: 50885403236240
• UDI-Public: 50885403236240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: ME2017
• Device Catalogue Number: ME2017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/04/2021
• 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