MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	2434-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set screw cap fell off into the nurse's hand when disconnecting the tubing from the patient.The following information was provided by the initial reporter: "a green curos cap was attached to the end of the tpn tubing upon disconnecting this tubing from the patient.Upon doing so, the screw cap that the curos cap screws in to fell off into the rns hand.New tpn tubing had to be opened and hung with the bag of tpn.No patient harm.".
Additional Manufacturer Narrative
Investigation summary: a sample was received and investigated with the customer's complaint of separation.The separation was not immediately noticed until the manufacturer's design document was analyzed and the missing piece (luer lock).The set was then inspected visually under microscope to determine that the failure was due to excess mechanical stress and that the solvent had been properly applied during production.It appears that the end of set broke off cleanly where it was adhered to the male luer end.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 the bd alaris¿ pump module smartsite¿ infusion set screw cap fell off into the nurse's hand when disconnecting the tubing from the patient.The following information was provided by the initial reporter: "a green curos cap was attached to the end of the tpn tubing upon disconnecting this tubing from the patient.Upon doing so, the screw cap that the curos cap screws in to fell off into the rns hand.New tpn tubing had to be opened and hung with the bag of tpn.No patient harm.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET
• 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: 12693065
• Report Number: 9616066-2021-52298
• Device Sequence Number: 19893340
• Product Code: FPA
• UDI-Device Identifier: 37613203019690
• UDI-Public: 37613203019690
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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: Health Professional
• Device Model Number: 2434-0007
• Device Catalogue Number: 2434-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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