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

Catalog Number FOL0102

Device Problem Detachment Of Device Component (1104)

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 clip that holds the catheter to the statlock snapped away from the base a few times.As a result, the patient allegedly had to change more often.

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 contains adequate instructions and contraindications for use of the statlock device.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 clip that connects the catheter to the statlock snapped away from the base a few times.The patient allegedly had to change more often.

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: "do not alter the statlock® device or components.Procedure must be performed by trained personnel with knowledge of anatomical landmarks, safe technique and potential complications." (b)(4).

Event Description

It was reported that the clip that connects the catheter to the statlock snapped away from the base a few times.The patient allegedly had to change more often.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• 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: 6456125
• MDR Text Key: 71856178
• Report Number: 1018233-2017-01525
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: FOL0102
• Device Lot Number: JUAYF192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• 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