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	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the kit tablet experienced incorrect drug/concentration/dosing reported/recorded.The following information was provided by the initial reporter: material no.516704, batch no.91df1f51 dose mismatch.Time 08:01.Sensor #9430 tablet: cart-2.08:01 - cefazolin 1000 mg (total 2g).Clinician research coordinator who submitted the complaint stated the dose registered as 1050 mg instead of 1000 mg.
Event or Problem Description
It was reported that the kit tablet experienced incorrect drug/concentration/dosing reported/recorded.The following information was provided by the initial reporter: material no.516704, batch no.91df1f51 dose mismatch.Time 08:01.Sensor #9430 tablet: cart-2.08:01 - cefazolin 1000 mg (total 2g).Clinician research coordinator who submitted the complaint stated the dose registered as 1050 mg instead of 1000 mg.
Additional Manufacturer Narrative
H6: 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.Based on the quality team's investigation, the system preformed as designed.

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11492233
• Report Number: 2243072-2021-00800
• Device Sequence Number: 2964499
• 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: 20028T01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/16/2021
• 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