MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA SURESTEP TRAY

Model Number SCCS1002

Device Problems Nonstandard Device (1420); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that during an evaluation, the sensica system with a119108s would not recognize the pre-printed tube band in order to advance to the calibration screen.Mss tried it multiple different times but could not get it to work.When the mss used the tube band that came with the ring, the system recognized it right away.The device was not used on a patient, but used only in training.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.

Event Description

It was reported that during an evaluation, the sensica system with a119108s would not recognize the pre-printed tube band in order to advance to the calibration screen.Mss tried it multiple different times but could not get it to work.When the mss used the tube band that came with the ring, the system recognized it right away.The device was not used on a patient, but used only in training.

• Brand Name: SENSICA SURESTEP TRAY
• Type of Device: SENSICA SURESTEP TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14054247
• MDR Text Key: 289020673
• Report Number: 1018233-2022-02149
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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
• Device Operator: Health Professional
• Device Model Number: SCCS1002
• Device Catalogue Number: A119108S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other