MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY; STATLOCK DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.H3 other text : the device was not returned.

Event Description

It was reported that during literature review for the statlock clinical evaluation report, it was stated that the project was conducted in a 1:1 ratio, to 1 of 2 groups as the experimental group had their indwelling bladder catheters secured in place by using the statlock device and the control group continued to utilize their prestudy traditional methods that included tape, velcro strap, cath-secure or none.Bladder catheters were changed at enrollment and every 4 weeks (as per preexisting practices of the participating hospitals) or earlier in case of catheter blockage.Both the statlock and the control securing devices were changed every week (according to preexisting practices of the participating hospitals).Of 127 enrolled patients, 9 were not followed for more than 10 days and, therefore, were excluded from analysis.The 9 excluded patients included 5 in the experimental group (2 voluntarily withdrew from the study and 3 developed urinary tract infections as 10 days after enrollment) and 4 in the control group (1 withdrew from the study and 3 developed urinary tract infections as 10 days after enrollment).A total of 118 patients (60 in the experimental group and 58 in the control group) were evaluable.Stated that 8 of 60 patients in the experimental group versus 14 of 58 patients in the control group developed symptomatic urinary tract infections.The statistically insignificant trend for lower incidence of symptomatic urinary tract infections in association with the use of the statlock device versus control measures existed regardless of whether patients used a transurethral catheter (7 of 40, 18.5% versus 12 of 41, 29%, respectively) or a suprapubic catheter (1 of 20, 5% versus 2 of 17, 11.8%, respectively).There were no statistically significant differences in the rates of catheter dislodgement and urethral meatal erosion in patients whose catheters were secured in place by using the statlock device versus other measures.It was unknown what medical intervention was provided for urinary tract infections.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "materials of construction are not biocompatible".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd was unable to determine the associated labeling to review.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.H3 other text: the device was not returned.

Event Description

It was reported that during literature review for the statlock clinical evaluation report, it was stated that the project was conducted in a 1:1 ratio, to 1 of 2 groups as the experimental group had their indwelling bladder catheters secured in place by using the statlock device and the control group continued to utilize their prestudy traditional methods that included tape, velcro strap, cath-secure or none.Bladder catheters were changed at enrollment and every 4 weeks (as per preexisting practices of the participating hospitals) or earlier in case of catheter blockage.Both the statlock and the control securing devices were changed every week (according to preexisting practices of the participating hospitals).Of 127 enrolled patients, 9 were not followed for more than 10 days and, therefore, were excluded from analysis.The 9 excluded patients included 5 in the experimental group (2 voluntarily withdrew from the study and 3 developed urinary tract infections as 10 days after enrollment) and 4 in the control group (1 withdrew from the study and 3 developed urinary tract infections as 10 days after enrollment).A total of 118 patients (60 in the experimental group and 58 in the control group) were evaluable.Stated that 8 of 60 patients in the experimental group versus 14 of 58 patients in the control group developed symptomatic urinary tract infections.The statistically insignificant trend for lower incidence of symptomatic urinary tract infections in association with the use of the statlock device versus control measures existed regardless of whether patients used a transurethral catheter (7 of 40, 18.5% versus 12 of 41, 29%, respectively) or a suprapubic catheter (1 of 20, 5% versus 2 of 17, 11.8%, respectively).There were no statistically significant differences in the rates of catheter dislodgement and urethral meatal erosion in patients whose catheters were secured in place by using the statlock device versus other measures.It was unknown what medical intervention was provided for urinary tract infections.

• Brand Name: STATLOCK SL FOLEY
• Type of Device: STATLOCK DEVICE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17798953
• MDR Text Key: 324041232
• Report Number: 1018233-2023-07007
• Device Sequence Number: 1
• Product Code: EYJ
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/09/2023
• 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