MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL FOLEY STABILIZATION DEVICE, TRICOT ANCHOR PAD, FOR SILICONE CATHETERS; STATLOCK

Catalog Number FOL0102

Device Problem Difficult to Open or Close (2921)

Patient Problem Urinary Retention (2119)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that there was an unknown issue with a statlock.It was further clarified that the statlock did not work with the new clear catheters, and would not reliably stay closed.The new catheters were larger, and when forced into the statlock, they allegedly stopped the urine flow.The catheters and statlock were inspected and tested before use.There was 450cc of urine retained.However, this did not delay the procedure.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "indications for use: the statlock device is a stabilization device for compatible catheters.Application technique prep place foley catheter into retainer.Directional arrow should point towards catheter tip, and balloon inflation arm should be next to the clamp hinge.Close lid, being careful to avoid pinching the catheter.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.After placing the statlock stabilization device off to the side, cleanse and degrease the securement site with alcohol per hospital policy.Let skin dry.Apply skin protectant, in direction of hair growth, to area larger than securement site.Allow to dry completely (10-15 seconds).Using permanent marker, write initials and date of application on the statlock device anchor pad.Note: always secure catheter into the statlock device retainer before applying adhesive pad on skin." (b)(4).

Event Description

It was reported that there was an unknown issue with a statlock.It was further clarified that the statlock did not work with the new clear catheters, and would not reliably stay closed.The new catheters were larger, and when forced into the statlock, they allegedly stopped the urine flow.The catheters and statlock were inspected and tested before use.There was 450cc of urine retained.However, this did not delay the procedure.

• Brand Name: SL FOLEY STABILIZATION DEVICE, TRICOT ANCHOR PAD, FOR SILICONE CATHETERS
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; parque industrial aeropuerto; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; parque industrial aeropuerto; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6446015
• MDR Text Key: 71495208
• Report Number: 1018233-2017-01423
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Home Health Aide
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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: Other
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: FOL0102
• Device Lot Number: JUZIF375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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