MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 SL FOLEY SWIVEL 3-WAY SILICONE TRICOT; STATLOCK

Catalog Number FOL0105

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

No sample is being returned for evaluation.The lot # is unknown, therefore the device history record could not be reviewed.The instructions for use states the following: "the document is sufficiently clear in the description of the application and use of the product, specifically sections: daily maintenance and application technique: daily maintenance: use clinical judgment on the removal of the statlock stabilization device if the patient experiences any fluid shifts that may interfere with skin integrity application technique: prep 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." (b)(4).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.Sample was discarded.

Event Description

It was reported that the patients received an inner thigh blister.The complainant alleged that when patients receive high amounts of fluids, patients become swollen throughout their extremities, and the statlock creates a blister on the patients' thigh.The device should be placed on the anterior part of the thigh and never at the inner thigh.Furthermore, the device should not be used on patients with fluid shifts.

• Brand Name: SL FOLEY SWIVEL 3-WAY SILICONE TRICOT
• Type of Device: STATLOCK
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5604863
• MDR Text Key: 43536031
• Report Number: 1018233-2016-00507
• Device Sequence Number: 1
• Product Code: KMK
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FOL0105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2016
• 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