LUBRI-SIL FOLEY CATHETERS
Report
- Report Number
- 1018233-2022-02851
- Event Type
- Malfunction
- Date Received
- April 22, 2022
- Date of Event
- March 28, 2022
- Report Date
- May 9, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- PMA / PMN Number
- K040504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿LUMEN WALL THICKNESS UNDERSIZED". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE SILICONE. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. ¿ USE LUER TIP SYRINGE TO INFLATE WITH STATED ML OF STERILE WATER. OR ¿ FOR PRE-FILLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFLATE WITH STATED ML OF STERILE WATER. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. FOR UROLOGICAL USE ONLY. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. IF NECESSARY, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS.¿ H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, PAIN, URETHRAL OR BLADDER TRAUMA (PR# (B)(4)), CATHETER BLOCKAGE AND LEAKAGE WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE LUBRI-SIL AQUAFIL HYDROGEL COATED ALL SILICONE FOLEY CATHETER (D1758 (12-24E)). IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, PAIN, URETHRAL OR BLADDER TRAUMA (PR# 4840103), CATHETER BLOCKAGE AND LEAKAGE WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE LUBRI-SIL AQUAFIL HYDROGEL COATED ALL SILICONE FOLEY CATHETER (D1758 (12-24E)). IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199681 | LUBRI-SIL FOLEY CATHETERS | UNKNOWN FOLEY CATHETER | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |