MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICROBORE EXTENSION SET, IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9267
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: two photos of extension set, model mz9267, was received by the customer for investigation.A 3 ml syringe could be seen to be attached to the maxzero within one photo.The photos of the extension set were visually inspected and a leak was apparent.The customer's complaint of a leak while using bd 3 ml luer lok syringe (ref (b)(4)) when attached to the bd maxzero microbore extension set tubing was verified.A device history record review could not be performed on model mz9267 because a lot number was not provided by the customer.Since no physical sample was received, an investigation could not be performed and a root cause could not be determined.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 the microbore extension set, iv connector leaked at the end of the gentamicin infusion.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "we encountered a leak while using bd 3 ml luer lok syringe (ref (b)(4)) when attached to the bd maxzero microbore extension set tubing (ref (b)(4)).Gentamicin was infusing in a patient over 30 minutes and at the end of infusion, fluid was noted on the syringe, tubing, and iv syringe pump.Patient was not harmed.".
Event or Problem Description
It was reported that the microbore extension set, iv connector leaked at the end of the gentamicin infusion.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "we encountered a leak while using bd 3 ml luer lok syringe (ref 309657) when attached to the bd maxzero microbore extension set tubing (ref mz9267).Gentamicin was infusing in a patient over 30 minutes and at the end of infusion, fluid was noted on the syringe, tubing, and iv syringe pump.Patient was not harmed.".
Additional Manufacturer Narrative
H6: investigation summary: two photos of extension set, model mz9267, was received by the customer for investigation.A 3 ml syringe could be seen to be attached to the maxzero within one photo.The photos of the extension set were visually inspected and a leak was apparent.The customer's complaint of a leak while using bd 3 ml luer lok syringe (ref 309657) when attached to the bd maxzero microbore extension set tubing was verified.A device history record review could not be performed on model mz9267 because a lot number was not provided by the customer.Since no physical sample was received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR
• 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: 12019159
• Report Number: 9616066-2021-51334
• Device Sequence Number: 19992562
• Product Code: FPA
• UDI-Device Identifier: 50885403240728
• UDI-Public: 50885403240728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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: MZ9267
• Device Catalogue Number: MZ9267
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1