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

Device Problem Fitting Problem (2183)

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

Event Date 08/03/2023

Event Type  malfunction  

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 the statlock would not lock/click close over foley.They had replaced in emergency department & office with same issue.Representative explained that bd had 3 types of statlock foleys, one designed for latex foley catheters, one for silicone foley catheters and one universal that should fit both, if they were using a statlock for a material that was not designed then the statlock may not fit.

Event Description

It was reported that the statlock would not lock/click close over foley.They had replaced in emergency department & office with same issue.Representative explained that bd had 3 types of statlock foleys, one designed for latex foley catheters, one for silicone foley catheters and one universal that should fit both, if they were using a statlock for a material that was not designed then the statlock may not fit.Per follow up via phone on (b)(6) 2023, it was reported that they had an intermittent catheter in for 10 days, and the several statlocks they used would fall off completely if any tension came to the statlocks.They spoke with urologist to find alternatives and/or substitutes, but they felt the clasp was not the right fit for the catheters they used them with.Also made note that some slight irritation occurred where the statlocks were placed, and they were trying to alleviate the soreness.

Manufacturer Narrative

The reported event was inconclusive.A potential root cause for this failure could be due to "inappropriate snap fit ".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog and 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.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN 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: 17585693
• MDR Text Key: 321556437
• Report Number: 1018233-2023-06181
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/13/2023
• 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