MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MINIBORE BI-FUSE PRESSURE 2 IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ5307
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 18 minibore bi-fuse pressure 2 iv connectors experienced damaged or open unit packaging/seal where sterility was compromised.The following information was provided by the initial reporter: material #: mz5307, batch/lot #: 20126424.Pacu team said that they are seeing a defect around the sealing of the package in product #mz5307.It looks like the plastic didn¿t adhere together.
Additional Manufacturer Narrative
H.6.Investigation: a complaint of packaging not being fully sealed was received from the customer.17 unopened samples were returned for investigation.Through visual inspection the customer complaint was verified.All 17 samples had packages that were not fully sealed.The manufacturing plant was then notified and they performed an investigation.A device history record review for model mz5307 lot number 20126424 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 for the defect was determined to be a dirty mold on the manufacturing machine leading to the product not being fully sealed.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of packaging issues with lot #20126424 regarding item mz5307.H3 other text : see h.10.
Event or Problem Description
It was reported that 18 minibore bi-fuse pressure 2 iv connectors experienced damaged or open unit packaging/seal where sterility was compromised.The following information was provided by the initial reporter: material #: mz5307 batch/lot #: 20126424.Pacu team said that they are seeing a defect around the sealing of the package in product #mz5307.It looks like the plastic didn¿t adhere together.

• Brand Name: MINIBORE BI-FUSE PRESSURE 2 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: 11996773
• Report Number: 9616066-2021-51312
• Device Sequence Number: 14342677
• Product Code: FPA
• UDI-Device Identifier: 50885403230606
• UDI-Public: 50885403230606
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/01/2021

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: MZ5307
• Device Catalogue Number: MZ5307
• Device Lot Number: 20126424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/14/2021
• 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