MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SENSOR; INTELLIPORT SYSTEM

Model Number	516700
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that sensor had screen issues with the tablet.The following information was provided by the initial reporter: material no.516700, batch no.Unknown.It is reported customer experienced screen issues with tablet.Verbiage received, - senor #9302 was prepared according to ifu using two 10ml flush syringes.After two syringes, tablet still displayed "continue flushing" message.Customer flushed again using two 5ml pushes from a third 10ml flush syringe.Tablet still displayed continue flushing" message, so customer got a fourth 10ml flush syringe and pushed two more 5ml pushes.Tablet still displayed a "continue flushing" message.At that point, the customer set the sensor aside and opened a new one.The new sensor turned to "ready" state after only one 10ml flush syringe was used to prep.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-04-28.H6: investigation summary one sensor was 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.An investigation was conducted on the sample to determine why the sample was not in the ready state.Inspection of the sensor shows that the crystal adhesive may have spread out too much and it increased the chance for the spring contact to disconnect from the crystal.When the sensor was in use, an electrical disconnect prevented the sensor from observing the signal, however when the sample was tested in the lab, the connection occurred and the signal was normal.
Event or Problem Description
It was reported that sensor had screen issues with the tablet.The following information was provided by the initial reporter: material no.516700, batch no.Unknown it is reported customer experienced screen issues with tablet.Verbiage received, - senor #9302 was prepared according to ifu using two 10ml flush syringes.After two syringes, tablet still displayed "continue flushing" message.Customer flushed again using two 5ml pushes from a third 10ml flush syringe.Tablet still displayed continue flushing" message, so customer got a fourth 10ml flush syringe and pushed two more 5ml pushes.Tablet still displayed a "continue flushing" message.At that point, the customer set the sensor aside and opened a new one.The new sensor turned to "ready" state after only one 10ml flush syringe was used to prep.

• Brand Name: SENSOR
• Common Device Name: INTELLIPORT SYSTEM
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11276906
• Report Number: 9610847-2021-00057
• Device Sequence Number: 2689054
• Product Code: PHC
• UDI-Device Identifier: 50382905167008
• UDI-Public: 50382905167008
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Expiration Date: 01/31/2021
• Device Model Number: 516700
• Device Catalogue Number: 516700
• Device Lot Number: 0041254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/03/2021
• 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