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

Model Number	516704
Medical Device Problem Codes	Incorrect Measurement (1383); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
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.A device history record review found no non-conformances associated with this issue during production of this batch.After investigation, the team found that the first occurrence was an undermeasurement which may be due to microbubbles.The drug charted, propofol, is known to have significant bubbles in the liquid.This dose will be considered an undermeasurement and monitored.The second occurrence may be due to the user attaching and detaching a syringe without giving a dose or the syringe was attached at an angle and as the user started the push, the sensor switch lever disengaged from the base switch.The system treated this as a detach event and the bolus was not recorded after.This bolus was flagged by the system and therefore the system behaved as expected.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the kit tablet measured the amount of propofol incorrectly, and did not record the vecuronium.The following information was provided by the initial reporter: "the device measured the amount of propofol wrong and didn't measure the vecuronium at all.".

• 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: 12073077
• Report Number: 2243072-2021-01761
• Device Sequence Number: 3910062
• 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): 06/16/2021

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: 20028T02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1