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

Device Problem Illegible Information (4050)

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

Event Date 10/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the customer was not told to keep the foley statlocks dry nor were the instruction for use (ifu) in the package clear.Stated that the foley statlocks fall off since they discharge from the hospital two days ago, when the statlock get wet from the shower they fall off and they used a piece of masking tape to keep foley from tugging to get to their doctor¿s office to get more statlocks.Inquirer responded that the statlock device might need to be changed more frequently than every seven days if it loses complete contact with the skin.Skin should be clean, dry, and free from any lotions or oils.The pads adhesive comes off quicker the more a person showers.Suggested to cover the statlock with plastic wrap or waterproof dressing during showering or bathing to kept it dry.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "missing instructions".It was 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 was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "daily maintenance: a.The statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.C.If showering/bathing, cover with plastic wrap or waterproof dressing.D.Conduct skin assessment prior to application and repeat daily per facility protocol." 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 customer was not told to keep the foley statlocks dry nor were the instruction for use (ifu) in the package clear.Stated that the foley statlocks fall off since they discharge from the hospital two days ago, when the statlock get wet from the shower they fall off and they used a piece of masking tape to keep foley from tugging to get to their doctor¿s office to get more statlocks.Inquirer responded that the statlock device might need to be changed more frequently than every seven days if it loses complete contact with the skin.Skin should be clean, dry, and free from any lotions or oils.The pads adhesive comes off quicker the more a person showers.Suggested to cover the statlock with plastic wrap or waterproof dressing during showering or bathing to kept it dry.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN FOLEY STATLOCK
• 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: 15596773
• MDR Text Key: 302376485
• Report Number: 1018233-2022-07819
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• 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