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

Catalog Number FOL0101

Device Problems Disconnection (1171); Failure to Form Staple (2579)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 clips would not stay closed on 3 of the devices.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted 21 unopened and 1 used foley statlocks were received.Visual evaluation noted no obvious defects.Samples were tested.All clamps were able to open and close properly.A 16 fr foley catheter was inserted into each device, the clamp door was able to close on all of them.For 4 of the samples tested, the clamp stayed closed while excessive force was applied to the catheter.The one used statlock opened with very little force 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: ¿the statlock device is a stabilization device for compatible catheters.".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 clips would not stay closed on 3 of the devices.No medical intervention was reported.

• Brand Name: SL FOLEY SWIVEL 25BX
• Type of Device: STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8732733
• MDR Text Key: 149328923
• Report Number: 1018233-2019-03362
• 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

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: FOL0101
• Device Lot Number: JUDQF191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1