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

Device Problems Fitting Problem (2183); Malposition of Device (2616)

Patient Problems Discomfort (2330); Tissue Breakdown (2681)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the foley catheter was not staying centered within the statlock.Due to the catheter not being stable, the skin around the meatus wore away.No medical intervention reported.

Event Description

It was reported that the foley catheter was not staying centered within the statlock.Due to the catheter not being stable, the skin around the meatus wore away.No medical intervention reported.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be " clamp door opens unintentionally / incomplete engagement," and potential root cause for this failure could be" wrong catheter used".The lot number is unknown therefore the device history record could not be reviewed.A labeling review was not required due to the unknown product code.Therefore, bd was unable to determine the associated labeling to review.Although the product code is unknown, the intermittent catheter labeling was found to be adequate based on past reviews.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8728497
• MDR Text Key: 149077458
• Report Number: 1018233-2019-03328
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1