MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP BLD180M 15D DEHP; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015414
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris¿ lvp bld180m 15d dehp blood backflowed when the clamp did not hold appropriately.There was no report of patient impact.The following information was provided by the initial reporter: blood from prbc found to have back flowed into the saline bag despite being clamped appropriately.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that the blood from primary bag found to have back flowed into the saline bag despite being clamped appropriately could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 10015414 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported while using bd alaris¿ lvp bld180m 15d dehp blood backflowed when the clamp did not hold appropriately.There was no report of patient impact.The following information was provided by the initial reporter: blood from prbc found to have back flowed into the saline bag despite being clamped appropriately.

• Brand Name: BD ALARIS¿ LVP BLD180M 15D DEHP
• 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 ; 8015296192
• MDR Report Key: 16065720
• Report Number: 9616066-2022-02090
• Device Sequence Number: 16649144
• Product Code: FPA
• UDI-Device Identifier: 50885403233997
• UDI-Public: (01)50885403233997
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: Other
• Device Model Number: 10015414
• Device Catalogue Number: 10015414
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/14/2023
• 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