MAUDE Adverse Event Report: BECTON DICKINSON KIT TABLET; INFUSION SAFETY MANAGEMENT SOFTWARE

Model Number	516704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.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.Based on the quality team's investigation and the clinician's description, the system preformed as designed, as an idle-wait screen is displayed if a lost wireless connection event occurs.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the kit tablet base failed, showing a "waiting for the case to begin" screen during the surgery.The following information was provided by the initial reporter: "crna informed me that ipad was not working.When i got to the or the screen was showing ¿waiting for the case to begin¿ even though the case was in the middle of the surgery.The case ended for crna when procedure started after induction.".

• Brand Name: KIT TABLET
• Common Device Name: INFUSION SAFETY MANAGEMENT SOFTWARE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12062945
• Report Number: 2243072-2021-01746
• Device Sequence Number: 4110846
• 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
• Report Date (Section B): 06/14/2021

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: Health Professional
• Device Model Number: 516704
• Device Catalogue Number: 516704
• Device Lot Number: 20028T02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1