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

Model Number SCCS1002

Device Problem Component Missing (2306)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that the cell pin of the senica device was bent.As per email response on 29march2022, nurse stated that the device was not on a patient during reported event.At that time the nurse did not know how the pin was bent.Nurse stated that the device was coming in for repair.As per additional information received on (b)(6) 2022, the technician found while making the replacement of the rubber feet that the bottom plastic housing of the base was cracked, which could cause ingress in a wet situation, so he replaced the bottom housing which is included in the sub assembly pole base.The poles were permanently glued to the plastic base, so poles have to be replaced as well.Per sample evaluation results received on (b)(6) 2022, it was reported that several rubber feet (rm0301264) were missing.It was noted that the rubber feet that were replaced.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.H11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that the cell pin of the senica device was bent.As per email response on 29march2022, nurse stated that the device was not on a patient during reported event.At that time the nurse did not know how the pin was bent.Nurse stated that the device was coming in for repair.As per additional information received on 21sep2022, the technician found while making the replacement of the rubber feet that the bottom plastic housing of the base was cracked, which could cause ingress in a wet situation, so he replaced the bottom housing which is included in the sub assembly pole base.The poles were permanently glued to the plastic base, so poles have to be replaced as well.Per sample evaluation results received on 21sep2022, it was reported that several rubber feet (rm0301264) were missing.It was noted that the rubber feet that were replaced.

• Brand Name: SENSICA UO MONITOR
• Type of Device: SENSICA UO MONITOR
• 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: 15594686
• MDR Text Key: 306512124
• Report Number: 1018233-2022-07794
• Device Sequence Number: 1
• Product Code: EXS
• 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: 12/26/2022

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: SCCS1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other