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

Catalog Number FOL0100

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 device did not remain closed around the catheter.

Manufacturer Narrative

Received 1 statlock swivel clamp in open packaging.The reported event was unconfirmed as the problem could not be reproduced.The sample received was visually inspected.There were no obvious defects detected on the pad and retainer of the sample.As part of the functional testing the retainer was opened and closed several times with no issues detected that were associated with the reported complaint.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".(b)(4).

Event Description

It was reported that the device did not remain closed around the catheter.

• Brand Name: SL FOLEY SWIVEL SILICONE 25BX
• Type of Device: STATLOCK FOLEY
• 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: 6688668
• MDR Text Key: 79235138
• Report Number: 1018233-2017-03458
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076077
• UDI-Public: (01)00801741076077
• 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
• Type of Report: Initial,Followup
• Report Date: 09/10/2017

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: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: FOL0100
• Device Lot Number: JUBNF526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• 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