MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1032
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood and saline leaked from the bd maxguard¿ extension set after attaching the stopcock, getting onto the echo keyboard and technician's forehead.The following information was provided by the initial reporter: "iv place for bubble study and definity.Iv was place left hand, patient tolerated well.Bd maxguard extension set.Was attached along with discfix 3-way stopcock.Iv flushed well, however when pushing agitated normal saline after attaching 3-way stopcock ns mixed with patient blood spilled out of the iv extension getting echo keyboard wet and echo tech xxx reported he felt a splash on his forehead/face.Replaced bd maxguard extension set and discfix 3-way stopcock, iv still with good flush.And with new extension bubble study and definity study was able to be completed.Patient tolerated study well, removal of iv was done by me (xxx).Xxx notified rn about incident who informed supervisor.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of leakage and splash out could not be verified due to the product not being returned for failure investigation.Device history record review for model me1032 lot number 22029602 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
It was reported that blood and saline leaked from the bd maxguard¿ extension set after attaching the stopcock, getting onto the echo keyboard and technician's forehead.The following information was provided by the initial reporter: "iv place for bubble study and definity.Iv was place left hand, patient tolerated well.Bd maxguard extension set.Was attached along with discfix 3-way stopcock.Iv flushed well, however when pushing agitated normal saline after attaching 3-way stopcock ns mixed with patient blood spilled out of the iv extension getting echo keyboard wet and echo tech xxx reported he felt a splash on his forehead/face.Replaced bd maxguard extension set and discfix 3-way stopcock, iv still with good flush.And with new extension bubble study and definity study was able to be completed.Patient tolerated study well, removal of iv was done by me (xxx).Xxx notified rn about incident who informed supervisor.".

• Brand Name: BD MAXGUARD¿ 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16714488
• Report Number: 9616066-2023-00662
• Device Sequence Number: 1614567
• Product Code: FPA
• UDI-Device Identifier: 10885403235979
• UDI-Public: 10885403235979
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/10/2023

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 Catalogue Number: ME1032
• Device Lot Number: 22029602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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
• Patient Sex: Unknown