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

Model Number	516704
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
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: 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.(b)(4).
Event or Problem Description
It was reported that kit tablet reported incorrect dosing.This occurred on 11 occasions.The following information was provided by the initial reporter: material no.516704, batch no.By0f7z1.It is reported customer experienced incorrect reporting of dosages.
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 there was an accumulation of fluid before the bubble and the user's thumb on the plunger delivered this fluid.Based on the quality team's investigation, the system preformed as designed in seven of the occurrences.In four of the occurrences, it is likely there was a bubble in the system that will cause an undermeasurement, the team will monitor the system for any trends.H3 other text : see h10.
Event or Problem Description
It was reported that kit tablet reported incorrect dosing.This occurred on 11 occasions.The following information was provided by the initial reporter: material no.516704, batch no.By0f7z1.It is reported customer experienced incorrect reporting of dosages.

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11389231
• Report Number: 2243072-2021-00645
• Device Sequence Number: 11797280
• Product Code: PHC
• UDI-Device Identifier: 00382905167041
• UDI-Public: 00382905167041
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 02/03/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/26/2021
• 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