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

Model Number	516704
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd intelliport¿ tablet kit failed to transfer the newest patient data between care areas.The following information was provided by the initial reporter: "user notified that the intelliport tablet is not showing the newest patient that was sent by epic.".
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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: na.Investigation summary: no photos or samples were received by our quality team for evaluation.The certificate of compliance was reviewed and there are no non-conformances associated with this issue during production of this batch.During patient use of the intelliport system, there were observations that include an associate message for new patients not showing on tablets, allergy not showing up on tablets, and test patients showing up as an error.It was discovered that all these observations are related to the integration of the intelliport tablet device.Some of implementation fixes have been implemented.This includes fixing the hl7 messages so the workstation id lines send disassociation messages as the tablets previously did not receive a disassociation message for previous patients, when this error was fixed, the test patient showing up as in error nonconformance stopped.After further investigation, the patients not showing up on the tablets are all without allergies.The automatic conversion of "no known environmental allergies" to "no known allergies" was stopped.This caused these patients to have a "no known environmental allergies" tablet allergy popup, but all patients appeared on the tablets.With these changes implemented, all patients are appearing on the tablets and these changes are not related to the intelliport software / hardware.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INTELLIPORT¿ TABLET KIT
• Common Device Name: INFUSION SAFETY MANAGEMENT SOFTWARE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14503579
• Report Number: 2243072-2022-00733
• Device Sequence Number: 14861472
• 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
• Report Date (Section B): 05/09/2022

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: 20154T08
• 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: 04/29/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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