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

Model Number FOL0100

Device Problems Nonstandard Device (1420); No Apparent Adverse Event (3189)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported that the patient had used the foley statlock catheter stabilization ever since the patient started using the catheter.It was stated that in the last shipment, they noticed the design of the statlock had changed and there was not a white cover anymore.The new statlock design was just gluing the catheter into place and sometimes when the patient pulled up the pant or the registered nurse pulled up for the patient, it snugs, and it would tear.It was also stated that before the patient could snap it into place, but now it was tearing it apart.They would like to go back to the original design that they could snap it back into place.Stated that any kind of pressure that put into the statlock with the catheter, it would just tear off.The patient really liked that statlock and would like the original design.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all 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.The device was not returned.

Event Description

It was reported that the patient had used the foley statlock catheter stabilization ever since the patient started using the catheter.It was stated that in the last shipment, they noticed the design of the statlock had changed and there was not a white cover anymore.The new statlock design was just gluing the catheter into place and sometimes when the patient pulled up the pant or the registered nurse pulled up for the patient, it snugs, and it would tear.It was also stated that before the patient could snap it into place, but now it was tearing it apart.They would like to go back to the original design that they could snap it back into place.Stated that any kind of pressure that put into the statlock with the catheter, it would just tear off.The patient really liked that statlock and would like the original design.

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 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.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14696840
• MDR Text Key: 294052264
• Report Number: 1018233-2022-04645
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FOL0100
• Device Catalogue Number: FOL0100
• Device Lot Number: JUFZ2066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female