MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 112 IN 15 DROP IV ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9128
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 3 112 in 15 drop iv administration sets leaked while using the syringe to inject iv medicine.The following information was provided by the initial reporter: while using bd maxguard 15 drops/ml iv set ports leaking when using 3 mll syringe to inject iv medicine.
Event or Problem Description
It was reported that 3 112 in 15 drop iv administration sets leaked while using the syringe to inject iv medicine.The following information was provided by the initial reporter: "while using bd maxguard 15 drops/ml iv set ports leaking when using 3 mll syringe to inject iv medicine.".
Additional Manufacturer Narrative
H6: investigation summary: 1 sample was received and tested by our quality team.The sample was tested with saline solution multiple times and no leak was noticed.A pressure test was performed as well but no leak was achieved.This failure is currently a high priority due to multiple reports.Specifically the 3ml connection to the maxplus/maxzero connectors.Due to the failure being known, the complaint of leakage has been verified but without more information, the root cause remains unknown.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.H3 other text : see h10.

• Brand Name: 112 IN 15 DROP IV ADMINISTRATION 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: 11822837
• Report Number: 9616066-2021-50986
• Device Sequence Number: 17254086
• Product Code: FPA
• UDI-Device Identifier: 50885403237629
• UDI-Public: 50885403237629
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/28/2021

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 Model Number: MX9128
• Device Catalogue Number: MX9128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1