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	03/01/2021
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 recorded the incorrect dosages.This occurred on 7 occasions.The following information was provided by the initial reporter: material no.516704, batch no.20028t03.It is reported customer experienced the recording of incorrect dosages.Verbiage received, - "case #156: time 10:20.Sensor #9450 tablet: cart-3.10:04 propofol 160 mg (16.0 ml) but registered 160 mg (16.5 ml).10:05 vecuronium 7 mg (7 ml) but registered 6.5 mg (6.5 ml).10:16 cefazolin 1000 mg (10 ml) but registered 900 mg (9 ml).10:16 cefazolin 1000 mg (10 ml) but registered 950 mg (9.5 ml).Case #157 time 13:00.Sensor #9471 tablet: cart-3.13:09 propofol 200 mg (20 ml) but registered 210 mg (21 ml).13:18 cefazolin 1000 mg (10.0 ml) but registered 1050 mg (10.5 ml).14:20 ondanstron hcl 4 mg (2 ml) but registered 2 mg (1 ml)".
Additional Manufacturer Narrative
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 occurance where the signal was dropped due to a bubble which resulted in an undermeasurement.This occurance will be monitored and tracked.All other occurances were within specifications and no problems were detected.
Event or Problem Description
It was reported that kit tablet recorded the incorrect dosages.This occurred on 7 occasions.The following information was provided by the initial reporter: material no.516704, batch no.20028t03 it is reported customer experienced the recording of incorrect dosages.Verbiage received, - "case #156: time 10:20.Sensor #9450 tablet: cart-3 10:04 propofol 160 mg (16.0 ml) but registered 160 mg (16.5 ml) 10:05 vecuronium 7 mg (7 ml) but registered 6.5 mg (6.5 ml) 10:16 cefazolin 1000 mg (10 ml) but registered 900 mg (9 ml) 10:16 cefazolin 1000 mg (10 ml) but registered 950 mg (9.5 ml) case #(b)(4) time 13:00.Sensor #9471 tablet: cart-3 13:09 propofol 200 mg (20 ml) but registered 210 mg (21 ml) 13:18 cefazolin 1000 mg (10.0 ml) but registered 1050 mg (10.5 ml) 14:20 ondanstron hcl 4 mg (2 ml) but registered 2 mg (1 ml)".

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11574521
• Report Number: 2243072-2021-00882
• Device Sequence Number: 4266370
• 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: Pharmacist
• 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: 03/01/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/26/2021
• 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