MAUDE Adverse Event Report: BECTON DICKINSON KIT TABLET; INTELLIPORT SYSTEM

Model Number	516704
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that kit tablet had recording issues.This occurred on 2 occasions.The following information was provided by the initial reporter: material no.516704, batch no.20028t02.It is reported customer performance issues with recording drugs and volumes.Verbiage received, - "1.Date: april 15 2021, case 218, cart-1, sensor 9404.From comment section in an intelliport phase iii survey: "lidocaine did not detect for unclear reason.08:36 lidocaine 60 mg (3 ml) but registered "volume not measured.Dose given?" - user input 3 ml (60 mg) at 8:38." "2.Date: april 15 2021, case 219, cart-1 sensor 9502.From comment section in an intelliport phase iii survey: "propofol dose not measured for unclear reason".11:51 propofol 50 mg (5.0 ml) but registered "confirm volume and dose" - user input 5 ml (50 mg) at 11:52.".
Additional Manufacturer Narrative
H.6.Investigation: 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 system correctly flagged a dose as unmeasurable due to a bubble and prompted the user manually input the dose into the system as well as a flagging a dose that did not add up to the correct amount.The system was working as designed.
Event or Problem Description
It was reported that kit tablet had recording issues.This occurred on 2 occasions.The following information was provided by the initial reporter: material no.516704, batch no.20028t02.It is reported customer performance issues with recording drugs and volumes.Verbiage received, - "1.Date: (b)(6) 2021, case 218, cart-1, sensor 9404.From comment section in an intelliport phase iii survey: "lidocaine did not detect for unclear reason.08:36 lidocaine 60 mg (3 ml) but registered "volume not measured.Dose given?" - user input 3 ml (60 mg) at 8:38." "2.Date: (b)(6) 2021, case 219, cart-1 sensor 9502.From comment section in an intelliport phase iii survey: "propofol dose not measured for unclear reason".11:51 propofol 50 mg (5.0 ml) but registered "confirm volume and dose" - user input 5 ml (50 mg) at 11:52.".

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11829443
• Report Number: 2243072-2021-01481
• Device Sequence Number: 4443517
• 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): 06/17/2021

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
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1