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

Model Number FOL0102

Device Problem Malposition of Device (2616)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  Injury  

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 patient was found to have 1 cm urethral split.Patient had indwelling catheter secured with a bard statlock.Deputy ward manager stated that he thought this was down to poor positioning of the statlock.Also stated that he felt that the statlock had been placed too low on the thigh and therefore the catheter would be under tension.Also highlighted that attention should be paid to ensure the patient was in the correct position with leg extended before identifying the correct location for the statlock.The deputy ward manager would reinforce the correct placement of statlock with staff on the ward through the ward social media and they provided 2 further statlock instruction for use posters with the offer of further support for training as required.It was unknown what medical intervention was provided for urethral split.

Event Description

It was reported that the patient was found to have 1 cm urethral split.Patient had indwelling catheter secured with a bard statlock.Deputy ward manager stated that he thought this was down to poor positioning of the statlock.Also stated that he felt that the statlock had been placed too low on the thigh and therefore the catheter would be under tension.Also highlighted that attention should be paid to ensure the patient was in the correct position with leg extended before identifying the correct location for the statlock.The deputy ward manager would reinforce the correct placement of statlock with staff on the ward through the ward social media and they provided 2 further statlock instruction for use posters with the offer of further support for training as required.It was unknown what medical intervention was provided for urethral split.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "user deviation from instructions for use".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "application technique: prep step #3: identify securement site by laying the device retainer on the front of the thigh, leaving 1 inch of catheter slack between insertion site and the statlock device retainer.Place and peel step #7.Align the statlock® stabilization device over securement site leaving 1 inch of catheter slack.Make sure leg is fully extended.Step #8.While holding the retainer to keep the pad in place, peel away paper backing, one side at a time and place tension-free on skin.¿ 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.

• 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: 12533665
• MDR Text Key: 273367450
• Report Number: 1018233-2021-06013
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076114
• UDI-Public: (01)00801741076114
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FOL0102
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• 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