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

Model Number FOL0102

Device Problem Component Missing (2306)

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

Event Date 11/11/2021

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 the customer noticed that the foley statlock packages did not contain 2 skin prep pads.It was stated that these devices were not staying on well since they only received one pad.The patient indicated that more recent products have been especially bad about sticking and came off in only a couple of hours of wear.The affected lots were (jufs1996, juew3293, jufq0574).

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.

Event Description

It was reported that the customer noticed that the foley statlock packages did not contain 2 skin prep pads.It was stated that these devices were not staying on well since they only received one pad.The patient indicated that more recent products have been especially bad about sticking and came off in only a couple of hours of wear.The affected lots were (jufs1996, juew3293, jufq0574).

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12913673
• MDR Text Key: 281578078
• Report Number: 1018233-2021-07672
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2024
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Device Lot Number: JUFQ0574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• 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