MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 STATLOCK FOLEY STABILIZATION DEVICE

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

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 complainant was using a 2 way statlock with a 3 way non-bard catheter, and the statlock "clamped" the catheter which allegedly caused no urine to drain.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "directions for use: use aseptic technique.Tighten all connections.Remove protector caps (a) as required.Connect female port (b) to fluid delivery line or device and prime/flush.Connect male port (c) to catheter hub.Open slide clamp (d) for unimpeded flow.Swab septum of injection site and smartsite device (if present) with preferred antiseptic.The device was not returned.

Event Description

It was reported that the complainant was using a 2 way statlock with a 3 way non-bard catheter, and the statlock "clamped" the catheter which allegedly caused no urine to drain.

• Brand Name: STATLOCK FOLEY STABILIZATION DEVICE
• 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: 6327609
• MDR Text Key: 67581520
• Report Number: 1018233-2017-00423
• 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
• Report Date: 07/08/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: 06/21/2017
• Supplement Dates FDA Received: 07/08/2017
• 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