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

Catalog Number FOL0101

Device Problems Kinked (1339); Fitting Problem (2183)

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.The device was not returned.

Event Description

It was reported that the statlock device for latex catheters would not close over the 16fr silver alloy coated silicone dover 605163ic and medline dynd141016 catheters the patient used ((b)(6)).The patient reported that the statlock would only close over the inflation port and alleged that this caused the statlock device to rotate during use and create a kink in the catheter ((b)(6)).

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.

Event Description

It was reported that the statlock device for latex catheters would not close over the 16fr silver alloy coated silicone dover 605163ic and medline dynd141016 catheters the patient used (b)(4).The patient reported that the statlock would only close over the inflation port and alleged that this caused the statlock device to rotate during use and create a kink in the catheter (b)(4).

• Brand Name: SL FOLEY SWIVEL 25BX
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6950859
• MDR Text Key: 90548694
• Report Number: 1018233-2017-05272
• Device Sequence Number: 1
• Product Code: EYJ
• UDI-Device Identifier: 00801741076091
• UDI-Public: (01)00801741076091
• Combination Product (y/n): N
• 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: 10/17/2017

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 Catalogue Number: FOL0101
• Device Lot Number: JUBRF553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 10/17/2017
• 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