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

Model Number	516704
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
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 incorrect dosing reported.This occurred on 4 occasions.The following information was provided by the initial reporter: material no.516704.Batch no.20028t02.It was reported that "multiple medication doses didn¿t match what was given on tablet".Verbiage- "multiple medication doses didn¿t match what was given on tablet".
Event or Problem Description
It was reported that kit tablet had incorrect dosing reported.This occurred on 4 occasions.The following information was provided by the initial reporter: material no.516704 batch no.20028t02 it was reported that "multiple medication doses didn¿t match what was given on tablet".Verbiage- "multiple medication doses didn¿t match what was given on tablet".
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.After investigation, the team found one occurrence where the signal was non-existent due to a bubble which resulted in a significant undermeasurement.After the bubble left the fluid path, the signal remained high.There was a different occurrence where there was an unmeasurable dose due to a bubble and the user accidently entered the wrong dose, no system issue was found.The third occurrence was within intelliport specifications and no problems were detected.This incident has been added to our database of reported incidents.H3 other text : see h10.

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11742412
• Report Number: 2243072-2021-01278
• Device Sequence Number: 4417845
• 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): 06/16/2021

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: 03/31/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1