BARDEX® FOLEY CATHETER SILICONE COATED
Report
- Report Number
- 1018233-2022-00739
- Event Type
- Malfunction
- Date Received
- February 18, 2022
- Date of Event
- November 9, 2021
- Report Date
- February 21, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KOD
- PMA / PMN Number
- K922431
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
THE REPORTED EVENT WAS CONFIRMED AND CAUSE UNKNOWN. THE REPORTED FAILURE WAS ABLE TO BE REPRODUCED. THE PRODUCT WAS USED FOR UROLOGICAL CARE. BASED ON THE PHOTO SAMPLE, IT WAS OBSERVED THAT THE BALLOON WAS BURST. HOWEVER, THE EXACT CAUSE OF HOW AND WHEN THE PROBLEM OCCURRED COULD NOT BE DETERMINED. HOWEVER, A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE USER RELATED (EXAMPLE: CONTACT WITH SHARP OBJECT)/ EXPOSURE TO PETROLATUM BASED PRODUCTS/ MECHANICAL FAILURE/ OPERATOR ERROR. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "APPLICABLE SCOPE: FOLEY CATHETERS ARE INTENDED FOR USE IN THE DRAINAGE OF URINE FROM THE BLADDER OF CHILDREN AND ADULTS. CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION. STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGED. WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY BURST BALLOON. DO NOT ASPIRATE URINE THROUGH THE DRAINAGE FUNNEL WALL. SINGLE USE ONLY. DO NOT RE-STERILIZE. FOR UROLOGICAL USE ONLY. BEFORE USING, PLEASE INSPECT VISUALLY WHETHER PRODUCTS ARE ALL COMPLETE OR SURFACE WEAR. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. 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. IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE MAY BE CUT OFF. IF THIS FAILS, CONTACT AN 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. STORAGE: CATHETERS NEED TO BE STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT LIGHT, PREFERABLY STORED IN THE ORIGINAL PACKING BOX. CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS EVALUATED
IT WAS REPORTED THAT AFTER THE PATIENT'S BLADDER LITHOTRIPSY, THE FOLEY CATHETER WAS INDWELLED FOR BLADDER IRRIGATION. THE CATHETER FELL OFF AFTER THE PATIENT'S BLADDER WAS RINSED, AND UPON INSPECTION THE BALLOON OF THE CATHETER WAS FOUND TO BE LEAKED. THIS LED TO SECONDARY INTUBATION, WHICH INCREASED THE PAIN OF THE PATIENT. SIMILAR PROBLEMS OCCURRED WITH THE CATHETER SEVERAL TIMES, AND IT WAS NOT LUBRICATED WITH PARAFFIN OIL. PER FOLLOW UP VIA IBC ON 10FEB2022, THE USER DID NOT USE PARAFFIN OIL AS LUBRICANT.
IT WAS REPORTED THAT AFTER THE PATIENT'S BLADDER LITHOTRIPSY, THE FOLEY CATHETER WAS INDWELLED FOR BLADDER IRRIGATION. THE CATHETER FELL OFF AFTER THE PATIENT'S BLADDER WAS RINSED, AND UPON INSPECTION THE BALLOON OF THE CATHETER WAS FOUND TO BE LEAKED. THIS LED TO SECONDARY INTUBATION, WHICH INCREASED THE PAIN OF THE PATIENT. SIMILAR PROBLEMS OCCURRED WITH THE CATHETER SEVERAL TIMES, AND IT WAS NOT LUBRICATED WITH PARAFFIN OIL. PER FOLLOW UP VIA IBC ON 10FEB2022, THE USER DID NOT USE PARAFFIN OIL AS LUBRICANT.
IT WAS REPORTED THAT AFTER THE PATIENT'S BLADDER LITHOTRIPSY, THE FOLEY CATHETER WAS INDWELLED FOR BLADDER IRRIGATION. THE CATHETER FELL OFF AFTER THE PATIENT'S BLADDER WAS RINSED, AND UPON INSPECTION THE BALLOON OF THE CATHETER WAS FOUND TO BE LEAKED. THIS LED TO SECONDARY INTUBATION, WHICH INCREASED THE PAIN OF THE PATIENT. SIMILAR PROBLEMS OCCURRED WITH THE CATHETER SEVERAL TIMES, AND IT WAS NOT LUBRICATED WITH PARAFFIN OIL. PER FOLLOW UP VIA IBC ON 10FEB2022, THE USER DID NOT USE PARAFFIN OIL AS LUBRICANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6351 | BARDEX® FOLEY CATHETER SILICONE COATED | FOLEY CATHETER | KOD | C.R. BARD, INC. (COVINGTON) -1018233 | MYDV4876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |