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	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is pride industries.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 a sensor communication failure.The following information was provided by the initial reporter: material no.516704.Batch no.20028t01.It was reported that the screen stated ¿sensor #9702 not ready¿ in red and then stated ¿continue flushing¿ in yellow.
Event or Problem Description
It was reported that kit tablet had a sensor communication failure.The following information was provided by the initial reporter: material no.516704; batch no.20028t01.It was reported that the screen stated ¿sensor #9702 not ready¿ in red and then stated ¿continue flushing¿ in yellow.
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.During use of the intelliport system, the injection site (base and sensor) is connected to the tablet.As result of the design of the firmware on the base, the base can reset itself to reduce failures of the intelliport bases.Due to the reset of the base, the injection site will turn from a ready state to a non-ready state.The clinicians are recommended and instructed to push saline syringe in order to ready intelliport.This is shown in the observations by the clinician.The intelliport system is working 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: 11682604
• Report Number: 2243072-2021-01193
• Device Sequence Number: 3610183
• 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: 03/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/16/2021
• 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