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

Model Number	516704
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
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 was not recording the medication dosages.The following information was provided by the initial reporter: "case #134: time 10 a.M.Tablet: cart-3.At 10:00: customer gave vecuronium-2 mg outside the intelliport.Additional info: the drug was given without using the intelliport sensor and hence was not recorded on tablet.At 10:46: crna pushed through 2mg vecuronium, which did not get registered.She also did not hear the tablet saying "vecuronium" as she attached and pushed through the medication.On select med popup, she accidently chose nicardipine.She then put 0 as the dose since nicardipine was not a medication that was given at the time.Customer said she did not have an option to add the drug dose for vecuronium (which did not register for her initially) note: customer used the same vecuronium syringe later and had no issues the second time she used it.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 20028t03, d4: medical device expiration date: na, h4: device manufacture date: 2020-02-07.H6: investigation summary: no photos or samples were received by our quality team for evaluation.Device history no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the system preformed as designed.
Event or Problem Description
It was reported that the kit tablet was not recording the medication dosages.The following information was provided by the initial reporter: "case #134: time 10 a.M.Tablet: cart-3.1) 10:00 customer gave vecuronium-2 mg ouside the intelliport.Additional info: the drug was given without using the intelliport sensor and hence was not recorded on tablet.2) 10:46: crna pushed through 2mg vecuronium, which did not get registered.She also did not hear the tablet saying "vecuronium" as she attached and pushed through the medication.On select med popup, she accidently chose nicardipine.She then put 0 as the dose since nicardipine was not a medication that was given at the time.Customer said she did not have an option to add the drug dose for vecuronium (which did not register for her initially) note: customer used the same vecuronium syringe later and had no issues the second time she used it.".

• 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: 11458155
• Report Number: 2243072-2021-00735
• Device Sequence Number: 3522667
• 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: Health Professional
• Device Model Number: 516704
• Device Catalogue Number: 516704
• Device Lot Number: 20028T03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/10/2021
• 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