MAUDE Adverse Event Report: BECTON DICKINSON KIT TABLET; INFUSION SAFETY MANAGEMENT SOFTWARE

Model Number	516704
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 kit tablet rebooted while in the middle of resolving medications.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "tablet shutdown tablet ¿ cart 2, case ¿ 117.The customer was in the middle of resolving medications and the tablet rebooted.The message " intelliport system down.Please contact a network administrator" showed up.Customer logged back into the tablet and patient setup screen showed up the case.Customer reconnected and then selected close down ports option".
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality for evaluation.A device history record review found no non-conformances associated with this issue during production of this batch.During investigation, it was found that the movement of the tablets can contribute to the tablet user interface issues such as slow response, tablet ui application crashes, and tablet hardware issues.To mitigate the issues, it was advised to the customer to reboot the tablet after changing tablet positioning (e.G.Changing rooms).
Event or Problem Description
It was reported that the kit tablet rebooted while in the middle of resolving medications.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "tablet shutdown tablet ¿ cart 2, case ¿ 117 the customer was in the middle of resolving medications and the tablet rebooted.The message " intelliport system down.Please contact a network administrator" showed up.Customer logged back into the tablet and patient setup screen showed up the case.Customer reconnected and then selected close down ports option.".

• Brand Name: KIT TABLET
• Common Device Name: INFUSION SAFETY MANAGEMENT SOFTWARE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11402982
• Report Number: 2243072-2021-00682
• Device Sequence Number: 11895300
• Product Code: PHC
• UDI-Device Identifier: 00382905167041
• UDI-Public: 00382905167041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182092
• 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): 05/19/2021

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: 516704
• Device Catalogue Number: 516704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1