MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MINIBORE PRESSURE RATED EXT, IV CNNCTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ5301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Fda device problem code(s): 1354.Fda patient problem code(s): 2199.
Event or Problem Description
It was reported that the minibore pressure rated ext, iv cnnctor experienced leakage.The following information was provided by the initial reporter: material no.: mz5301.Batch no.: 19035723.Nurse called to advise that lot #19035723 is leaking at the max zero or blue part when it is connected to the cadd or gravity tubing.
Event or Problem Description
It was reported that the minibore pressure rated ext, iv cnnctor experienced leakage.The following information was provided by the initial reporter: material no.: mz5301, batch no.: 19035723.Nurse called to advise that lot #19035723 is leaking at the max zero or blue part when it is connected to the cadd or gravity tubing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/29/2020.H.6.Investigation: 14 unopened maxzero extension sets, material # mz5301, lot # 19035723 was received by the customer for investigation.The samples were visually inspected and then tested for evidence of leakage.No defect was observed.The customer's complaint of leakage at the maxzero could not be verified and a root cause could not be determined.A device history record review for model mz5301 lot number 19035723 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A trend for the maxzero leakage issue has been identified for this product line.We have funded a project, capa#463557 to improve manufacturing processes and prevent future occurrences of this type.As part of the action plan, changes to the manufacturing machinery and process controls have been implemented.H3 other text : see h.10.

• Brand Name: MINIBORE PRESSURE RATED EXT, IV CNNCTOR
• 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 22244 ; MX 22244
• MDR Report Key: 10632445
• Report Number: 9616066-2020-20007
• Device Sequence Number: 14260978
• Product Code: FPA
• UDI-Device Identifier: 50885403230545
• UDI-Public: 50885403230545
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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 Expiration Date: 01/09/2022
• Device Model Number: MZ5301
• Device Catalogue Number: MZ5301
• Device Lot Number: 19035723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other