MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EX SET BI-FUSE 7" MICRO 1CV REM CON; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9292
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Initial reporter state: address information was not able to be obtained, therefore, co was used as a place holder based off reporters area code.(b)(6).
Event or Problem Description
It was reported that bd ex set bi-fuse 7" micro 1cv rem con tubing was defective.The following information was provided by the initial reporter: i have now gotten multiple comments now about fluid leaking from the max zero connection site.It is not happening with spin collar luer connections, but rather with syringes that are being placed on the max zero bifuse.
Additional Manufacturer Narrative
H.6.Investigation: no photo or sample was received with the customer's complaint of leakage.Without further information, the complaint cannot be verified and the root cause remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported that bd ex set bi-fuse 7" micro 1cv rem con tubing was defective.The following information was provided by the initial reporter: i have now gotten multiple comments now about fluid leaking from the max zero connection site.It is not happening with spin collar luer connections, but rather with syringes that are being placed on the max zero bifuse.

• Brand Name: BD EX SET BI-FUSE 7" MICRO 1CV REM CON
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12849414
• Report Number: 9616066-2021-52422
• Device Sequence Number: 4205578
• Product Code: FPA
• UDI-Device Identifier: 50885403417885
• UDI-Public: 50885403417885
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/30/2021

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: MZ9292
• Device Catalogue Number: MZ9292
• Device Lot Number: UNKNOWN
• 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: 10/22/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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