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

Model Number	516704
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 8 kit tablets experienced incorrect drug concentration/dosing reported/recorded.The following information was provided by the initial reporter: material no.516704 batch no.By0f7z1 dose mismatch: case #140: time 14:40.Sensor #9478 tablet: cart-3.12:32 - fentanyl -given 200mcg displayed as 225mcg.14:26- vecuronium-given 2mg displayed as 2.5mg.14:36 - zofran-given 4mg displayed as 3mg.Case #141: time 18:42.Sensor #9401 tablet: cart-3.16:20 - midazolam - given 2mg displayed as 2.5mg.16:32- ancef - given 1000mg displayed as 1050 mg.16:32- ancef - given 1000mg displayed as 1050 mg.17:31- vecuronium-given 2mg displayed as 2.5 mg.
Event or Problem Description
It was reported that 8 kit tablets experienced incorrect drug concentration/dosing reported/recorded.The following information was provided by the initial reporter: material no.516704, batch no.By0f7z1.Dose mismatch: case #140: time 14:40.Sensor #9478 tablet: cart-3; 12:32 - fentanyl -given 200mcg displayed as 225mcg; 14:26- vecuronium-given 2mg displayed as 2.5mg; 14:36 - zofran-given 4mg displayed as 3mg.Case #141: time 18:42.Sensor #9401 tablet: cart-3 16:20 - midazolam - given 2mg displayed as 2.5mg 16:32- ancef - given 1000mg displayed as 1050 mg 16:32- ancef - given 1000mg displayed as 1050 mg 17:31- vecuronium-given 2mg displayed as 2.5 mg.
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.A device history record review found no non-conformances associated with this issue during production of this batch.After investigation, the team found one occurance where the signal was dropped due to a bubble which resulted in an undermeasurement.This occurance will be monitored and tracked.All other occurances were within specifications and no problems were detected.

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11474188
• Report Number: 2243072-2021-00768
• Device Sequence Number: 4510805
• 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: 20028T03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1