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

Device Problem Disconnection (1171)

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

Event Date 05/17/2023

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: the device was not returned.

Event Description

It was reported that tube to the drain bag keeps slipping out and had to use tape.Per follow up via phone on (b)(6) 2023, it was reported that the statlock was not keeping the tube secure and it would come apart and issue has been resolved.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.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "inappropriate snap fit".It was unknown whether the device had met specifications.The product was used for treatment but it was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number are unknown.Therefore, bd is unable to determine the associated labeling to review.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 tube to the drain bag keeps slipping out and had to use tape.Per follow up via phone on 17may2023, it was reported that the statlock was not keeping the tube secure and it would come apart and issue has been resolved.Per follow up via phone on (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.

• 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: 17097442
• MDR Text Key: 316855930
• Report Number: 1018233-2023-04143
• 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

• 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: 05/17/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/13/2023
• 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