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

Device Problem Nonstandard Device (1420)

Patient Problem Skin Tears (2516)

Event Date 06/10/2022

Event Type  malfunction  

Event Description

It was reported that the customer asked how to remove remaining adhesive from a foley statlock that was removed at discharge from the hospital and also patient had skin tears from the removal of the statlock.It was also advised that they should consult the physician for evaluation of the skin tear and an alcohol could be used on intact skin only to remove remaining adhesive, or if needed a medical adhesive remover could be used on intact skin only.No medical intervention was reported.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿process error".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 is unable to determine the associated labeling to review.The device was not returned.

Event Description

It was reported that the customer asked how to remove remaining adhesive from a foley statlock that was removed at discharge from the hospital and also patient had skin tears from the removal of the statlock.It was also advised that they should consult the physician for evaluation of the skin tear and an alcohol could be used on intact skin only to remove remaining adhesive, or if needed a medical adhesive remover could be used on intact skin only.No medical intervention was reported.

• Brand Name: UNKNOWN STATLOCK FOLEY
• Type of Device: UNKNOWN STATLOCK 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14859648
• MDR Text Key: 302360021
• Report Number: 1018233-2022-05024
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• 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
• Date Manufacturer Received: 08/12/2022
• 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