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

Model Number FOL0102

Device Problem Disconnection (1171)

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

Event Date 12/02/2021

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 retainer (rotary clamp) on the foley statlock came off 3 days after the placement.

Event Description

It was reported that the retainer (rotary clamp) on the foley statlock came off 3 days after the placement.

Manufacturer Narrative

The reported event is confirmed- cause unknown.Visual evaluation noted 1 statlock stabilization device with no packaging was received where the clamp was disconnected from the base.The product failed to meet specifications.Although an exact cause could not be determined, a potential root cause is glue selection incompatible with pad substrate.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labelling review was not preformed because labeling would not have prevented the reported event.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 actual/suspected device was inspected.

• 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: 13128173
• MDR Text Key: 284529938
• Report Number: 1018233-2021-08648
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

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: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Device Lot Number: JUEN2660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 12/31/2021
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2020
• 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