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

Model Number	516704
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
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 had incorrect dosing recording.This occurred on 8 occasions.The following information was provided by the initial reporter: material no.516704, serial no.(b)(4).It is reported customer experienced inaccurate dose recording.Verbiage received, - "dose mismatch.Sensor # (b)(4); case id: (b)(6).At 11:52 - propofol - given 200mg, recorded as 225mg.At 12:02 - cefazolin - given 1000 mg.At 12:02 - cefazolin - given 1000 mg.At 14:19 - fentanyl - given 50mcg.Sensor # (b)(4); case id: (b)(6).At 16:21 - propofol - given 200mg.At 16:21 - vecuronium bromide - given 7mg.At 16:30 - cefazolin - given 1000 mg (total 2000mg).At 17:07 - vecuronium bromide - given 3mg".
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 two occurances where there was a low signal due to a bubble which resulted in an undermeasurement.These occurances 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 had incorrect dosing recording.This occurred on 8 occasions.The following information was provided by the initial reporter: material no.516704, serial no.(b)(4).It is reported customer experienced inaccurate dose recording.Verbiage received, - "dose mismatch, sensor # 9221; case id: (b)(4), 11:52 - propofol -given 200mg, recorded as 225mg; 12:02 - cefazolin -given 1000 mg, 12:02 - cefazolin -given 1000 mg, 14:19 - fentanyl -given 50mcg.Sensor # 9171; case id: (b)(4), 16:21 - propofol -given 200mg, 16:21 - vecuronium bromide - given 7mg, 16:30 - cefazolin -given 1000 mg ( total 2000mg), 17:07 vecuronium bromide - given 3mg.".

• Brand Name: KIT TABLET
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11336251
• Report Number: 2243072-2021-00335
• Device Sequence Number: 13651238
• 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): 04/22/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1