MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE; UNKNOWN STATLOCK DEVICE

Catalog Number UNKNOWN

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the vent behind the sample port on the foley trays would not allow the statlock from the male external catheter tray to be used.Customer has been pulling the statlock from the male external catheter kits and using them on foley trays.Stated that they tried statlock with the most recent version of ez lock, it did worked however it was a tighter fit.

Manufacturer Narrative

Upon further review, bd has determined this event is not reportable.H11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that the vent behind the sample port on the foley trays would not allow the statlock from the male external catheter tray to be used.Customer has been pulling the statlock from the male external catheter kits and using them on foley trays.Stated that they tried statlock with the most recent version of ez lock, it did worked however it was a tighter fit.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: UNKNOWN STATLOCK DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13911739
• MDR Text Key: 288125778
• Report Number: 1018233-2022-01587
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/10/2022
• 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
• Patient Outcome(s): Other