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

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

Patient Problems Swelling (2091); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/27/2020

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 customer had an indwelling foley, with a statlock stabilization device.The statlock was not staying closed even though the catheter was properly seated.The tape was applied to keep the catheter stabilized so it did not get pulled out and get swiveled.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.Visual inspection noted one photo sample was received.Visual evaluation of the photo sample noted a foley statlock is shown with a foley catheter in place with a piece of tape over the clamp base.Without the device being returned, the reported event could not be confirmed.A potential root cause for the reported failure could be bent tooth on clamp.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the foley statlock device product ifus were found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that customer had an indwelling foley, with a statlock stabilization device.The statlock was not staying closed even though the catheter was properly seated.The tape was applied to keep the catheter stabilized so it did not get pulled out and get swiveled.Per follow up via email on 02jan2021, customer stated that the silicone catheter size is 14.The original statlock was snapped shut when installed (applied to leg) and stayed shut for a couple of days.Once it opened, it was hard to keep shut and applied some medical adhesive tape over the lock to prevent it from opening.The statlock was disposed of.Per follow up via email on 02jan2021,also stated that the second statlock has worked very well, staying closed since applied and rotating with movement.One change made to move the leg back to the inside of the knee.It had been more to the outside and i believe that placed pressure on the statlock snap with movement.Once it was opened, it was then hard to keep shut.

• 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
• MDR Report Key: 11055250
• MDR Text Key: 223141595
• Report Number: 1018233-2020-21890
• 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: 04/19/2021

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
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other