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

Model Number	10013364
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ secondary set tubing snapped off and started leaking chemotherapy medicine after being prepared for use.The following information was provided by the initial reporter: "chemo was prepared in pharmacy and approved to go to administration.While in the bag the tubing snapped off and started leaking in the bag.They noticed it before it went out to the floor.This is now the second time in the last 6 days, and several of many to happen to this account.We have implemented an inspection of every tubing set to ensure it is not kinked before as well.".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary a photo was received and analyzed by our quality team.The photo provided had clear signs of separation below the drip chamber and the customer's complaint has been verified.Without a physical sample, the root cause of this failure remains unknown.A device history record review for model 10013364 lot number 21015483 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ secondary set tubing snapped off and started leaking chemotherapy medicine after being prepared for use.The following information was provided by the initial reporter: "chemo was prepared in pharmacy and approved to go to administration.While in the bag the tubing snapped off and started leaking in the bag.They noticed it before it went out to the floor.This is now the second time in the last 6 days, and several of many to happen to this account.We have implemented an inspection of every tubing set to ensure it is not kinked before as well.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ SECONDARY 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: 12829168
• Report Number: 9616066-2021-52437
• Device Sequence Number: 1520570
• Product Code: FPA
• UDI-Device Identifier: 50885403221925
• UDI-Public: 50885403221925
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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 Expiration Date: 01/07/2024
• Device Model Number: 10013364
• Device Catalogue Number: 10013364
• Device Lot Number: 21015483
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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