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

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	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that kit tablet recorded incorrect dosage.The following information was provided by the initial reporter: material no.516704, batch no.Bb4xr02.It is reported customer experienced incorrect dosage recording when using product.Verbiage received, - "case #142: time 11:53 a.M.Tablet: cart-2.Customer said "when i walked into the or to close down the case the tablet was showing "intelliport system is down.Please contact a network administrator".I was able to restart the tablet and bring back the case to properly close it out.I just wanted to bring this up to your attention in case you wanted to investigate this.Crna said that he was able to administer all medications before this even happened.".
Event or Problem Description
It was reported that kit tablet recorded incorrect dosage.The following information was provided by the initial reporter: material no.516704, batch no.Bb4xr02.It is reported customer experienced incorrect dosage recording when using product.Verbiage received, - "case # (b)(4): time 11:53 a.M.Tablet: cart-2.Customer said "when i walked into the or to close down the case the tablet was showing "intelliport system is down.Please contact a network administrator".I was able to restart the tablet and bring back the case to properly close it out.I just wanted to bring this up to your attention in case you wanted to investigate this.Crna said that he was able to administer all medications before this even happened.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 20028t01, d4: medical device expiration date: na, h4: device manufacture date: 2020-02-27.H6: investigation summary: no photos or samples were received by our quality for evaluation.A device history record review found no non-conformances associated with this issue during production of this batch.As part of the clinician study, the receiver application on the cce environment needs to be turned on.The clinician research coordinator did not turn on the receiver application on the cce application and therefore the doses did not get sent from the tablet to the gateway (laptop).There is no issue with the system and the situation that was described is caused by user.

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11483403
• Report Number: 2243072-2021-00788
• Device Sequence Number: 3412931
• 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: 02/15/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/15/2021
• 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