MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 60 IN NON-DEHP MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME2010
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 60 in non-dehp minibore extension set was difficult to disconnect and the tubing ruptured.The following information was provided by the initial reporter: material #: me2010 batch/lot #: unknown it was reported that they are experiencing issues with the tubing when trying to disconnect.Verbatim: we are experiencing issues with disconnection because the tubing functions differently from our normal tubing.We have had multiple issues with the tubing cracking/breaking when trying to disconnect.I believe the breaks are due to force and lack of knowledge about appropriate disconnection.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint of tubing cracking/breaking when trying to disconnect could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model me2010 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that 60 in non-dehp minibore extension set was difficult to disconnect and the tubing ruptured.The following information was provided by the initial reporter: material #: me2010 batch/lot #: unknown.It was reported that they are experiencing issues with the tubing when trying to disconnect.Verbatim: we are experiencing issues with disconnection because the tubing functions differently from our normal tubing.We have had multiple issues with the tubing cracking/breaking when trying to disconnect.I believe the breaks are due to force and lack of knowledge about appropriate disconnection.

• Brand Name: 60 IN NON-DEHP MINIBORE EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• MDR Report Key: 11697843
• Report Number: 9616066-2021-50771
• Device Sequence Number: 11545411
• Product Code: FPA
• UDI-Device Identifier: 10885403236235
• UDI-Public: 10885403236235
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/11/2021

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: Other
• Device Catalogue Number: ME2010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1