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

Model Number FOL0100

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

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 intermittent catheter was dried out but it would expire in 28nov2021.Per follow up via phone on (b)(6) 2021,customer had purchased ten packs of statlock and the preparation pads were dry but, it should have been good until 28nov2021.Customer purchased them in (b)(6) 2021 and had to buy additional preparation pads to supplement for the ones that were dry.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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.H3 other text : the device was not returned.

Event Description

It was reported that intermittent catheter was dried out but it would expire in (b)(6) 2021.Per follow up via phone on (b)(6) 2021,customer had purchased ten packs of statlock and the preparation pads were dry but, it should have been good until (b)(6) 2021.Customer purchased them in june 2021 and had to buy additional preparation pads to supplement for the ones that were dry.

• Brand Name: SL FOLEY SWIVEL SILICONE 25BX
• Type of Device: STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12355966
• MDR Text Key: 267746356
• Report Number: 1018233-2021-05109
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2021
• Device Model Number: FOL0100
• Device Catalogue Number: FOL0100
• Device Lot Number: JUCZF349
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other