MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 SL FOLEY STABILIZATION DEVICE, TRICOT ANCHOR PAD, FOR SILICONE CATHETERS; STATLOCK

Catalog Number FOL0102

Device Problems Failure To Adhere Or Bond (1031); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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 statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

Manufacturer Narrative

Received 1 used statlock device only.The sample received had evidence of use, as the pad assembly was received without the liners.A visual inspection was conducted to the parts that were returned.No damages or manufacturing defects were observed on the base, the clamp or short shots that could prevent the clamp from not closing properly or swivel as expected.There were no dimensional defects observed on the base.Other testing conducted indicated that a 20 fr, 1768si20 silicone does not fit.The drainage funnel is much larger in the 1768sixx series and the clip does not snap shut.It was also tested with 20fr latex, and 16ch silicone and it closed perfectly.The reported event was unconfirmed as the problem could not be reproduced.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "indications for use: "the statlock® device is a stabilization device for compatible catheters." (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.

Event Description

It was reported that the statlock would not stay in place when used with a 14fr catheter, and as a result, the catheter would twist and not allow urine to drain.It was also reported that the inflation lumen and drainage lumen would intertwine in the statlock, because the statlock would not stay in place.The patient allegedly had to visit the emergency room where the catheter was replaced.The patient allegedly had to use tape to keep the statlock and catheter in place, which allegedly caused the patient's skin to deteriorate.

• Brand Name: SL FOLEY STABILIZATION DEVICE, TRICOT ANCHOR PAD, FOR SILICONE CATHETERS
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5853717
• MDR Text Key: 52729004
• Report Number: 1018233-2016-01014
• Device Sequence Number: 1
• Product Code: EYJ
• 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: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention