MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY SWIVEL 25BX; STATLOCK

Catalog Number FOL0101

Device Problems Disconnection (1171); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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 statlock would not stay closed.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted one used foley statlock was returned.Visual evaluation noted no obvious defects.Clamp was able to open and close normally.A 16fr foley catheter was placed in the clamp.The clamp closed properly around the catheter, and the clamp door opened when slight pressure downward was applied to the catheter.A potential root cause for this failure could be material weakens due to over sterilization.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿7.Align the statlock stabilization device over securement sire leaving 1 inch of catheter slack.Make sure leg is fully extended." 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 the statlock would not stay closed.

• Brand Name: SL FOLEY SWIVEL 25BX
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8708106
• MDR Text Key: 148777521
• Report Number: 1018233-2019-03165
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076091
• UDI-Public: (01)00801741076091
• 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: 07/26/2019

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 Expiration Date: 07/28/2021
• Device Catalogue Number: FOL0101
• Device Lot Number: JUCVF314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1