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

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

Patient Problems Rash (2033); Urinary Tract Infection (2120)

Event Date 05/22/2023

Event Type  Injury  

Event Description

It was reported that the foley statlock did not work, and it did not close in place.Representative advised patient was using the statlock incorrectly and advised on proper use.Per follow up via phone on (b)(6) 2023, it was reported that patient was using latex foley, but they were switched to a silicone foley and the latex statlock did not fit the silicone foley.Per follow up via phone on (b)(6) 2023, it was reported that the patient's urologist stated that their suprapubic tube was clogged.It was supposed to hold for at least a month, but it continually failed.They switched from rubber to plastic, and the drain bag was not holding any urine as it was emptying over their clothes.They has to lean back in their wheelchair to relieve pressure on groin and buttocks.They were a quadriplegic, a rash and urinary tract infection developed because of the failing statlock.Also noted that the issue had since been resolved as they were back on the old statlocks they used years prior.Medical intervention was unknown.

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 foley statlock did not work, and it did not close in place.Representative advised patient was using the statlock incorrectly and advised on proper use.Per follow up via phone on 17may2023, it was reported that patient was using latex foley, but they were switched to a silicone foley and the latex statlock did not fit the silicone foley.Per follow up via phone on 22may2023, it was reported that the patient's urologist stated that their suprapubic tube was clogged.It was supposed to hold for at least a month, but it continually failed.They switched from rubber to plastic, and the drain bag was not holding any urine as it was emptying over their clothes.They has to lean back in their wheelchair to relieve pressure on groin and buttocks.They were a quadriplegic, a rash and urinary tract infection developed because of the failing statlock.Also noted that the issue had since been resolved as they were back on the old statlocks they used years prior.Medical intervention was unknown.

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" it is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number is 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 is 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: STATLOCK SL FOLEY
• 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: 17106038
• MDR Text Key: 316950234
• Report Number: 1018233-2023-04208
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• 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