BARDIA® FOLEY CATHETER SILICONE COATED
Report
- Report Number
- 1018233-2022-06377
- Event Type
- Malfunction
- Date Received
- August 15, 2022
- Date of Event
- July 12, 2022
- Report Date
- December 6, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZC
- UDI-DI
- 00801741095092
- PMA / PMN Number
- K910846
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME.
THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE THIN RUBBERIZE WALL THAT CAUSING COLLAPSE/PINCH INFLATION LUMEN UNDER THE BALLOON OR ALONG THE SHAFT¿. 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: "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, PREVENTING BALLOON DEFLATION. IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THE TAILS, CONTACT AN ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE AS DETECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT." H11: SECTION A THROUGH F - 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.
THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE DID NOT FAIL TO MEET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE THIN RUBBERIZE WALL THAT CAUSING COLLAPSE/PINCH INFLATION LUMEN UNDER THE BALLOON OR ALONG THE SHAFT¿. 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: "CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE BALLOON TO BURST. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SYRINGE. DO NOT USE NEEDLE. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. RECOMMENDED INFLATION CAPACITIES 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. NOTE: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LAWS AND REGULATIONS. 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, PREVENTING BALLOON DEFLATION. IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. 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." THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.
IT WAS REPORTED THAT THE FOLEY CATHETERS WERE PRESENTING DIFFICULTIES WHEN VERIFYING THAT THE BALLOON WAS IN GOOD CONDITION. DURING FILLING, IT WAS VERY COMPLICATED TO INTRODUCE THE LIQUID SOLUTION (DATE OF EVENT - UNK) AND WHEN EMPTYING THE CATHETER, THE SOLUTION CAME OUT SLOWLY AND EVEN SOME PROBES REMAINED WITH THE LIQUID INSIDE WHICH NEVER EMPTIED THE LIQUID PLACED. THE BALLOON MUST BE COMPLETELY DEFLATED WHEN REMOVED FROM THE PATIENT, BECAUSE IF IT WAS NOT DEFLATED CORRECTLY THEN IT COULD GENERATE HEALTH RISKS OF GREAT IMPACT (DATE OF EVENT - UNK). IT WAS MENTIONED THAT SEVEN PROBES HAD BEEN REPORTED FROM THE SURGICAL AREA AND THEY WERE USING A 5 ML INSUFFLATION SYRINGE. AS PER THE VIDEO SAMPLE REPORTED, IT WAS HARD TO INFUSE AND REQUIRED TOO MUCH EFFORT. THIS WAS TO VERIFY THAT THE BALLOON WAS NOT RUPTURED AND THERE WAS NO LEAK. WHEN THE USER TRIED TO REMOVE THE WATER FROM THE BALLOON OF THE PROBE, THE LIQUID DID NOT COME OUT DURING THE PREPARATION OF THE RRDY PATIENT PROCEDURE (DATE OF EVENT - (B)(6)2022). THE USER TRIED TWICE MORE, BUT IT WAS NOT POSSIBLE TO REMOVE THE WATER FROM THE BALLOON OF THE PROBE DURING THE PREPARATION OF THE PATIENT'S PROCEDURE PNR (DATE OF EVENT -(B)(6)2022).
IT WAS REPORTED THAT THE FOLEY CATHETERS WERE PRESENTING DIFFICULTIES WHEN VERIFYING THAT THE BALLOON WAS IN GOOD CONDITION. DURING FILLING, IT WAS VERY COMPLICATED TO INTRODUCE THE LIQUID SOLUTION (DATE OF EVENT - UNK) AND WHEN EMPTYING THE CATHETER, THE SOLUTION CAME OUT SLOWLY AND EVEN SOME PROBES REMAINED WITH THE LIQUID INSIDE WHICH NEVER EMPTIED THE LIQUID PLACED. THE BALLOON MUST BE COMPLETELY DEFLATED WHEN REMOVED FROM THE PATIENT, BECAUSE IF IT WAS NOT DEFLATED CORRECTLY THEN IT COULD GENERATE HEALTH RISKS OF GREAT IMPACT (DATE OF EVENT - UNK). IT WAS MENTIONED THAT SEVEN PROBES HAD BEEN REPORTED FROM THE SURGICAL AREA AND THEY WERE USING A 5 ML INSUFFLATION SYRINGE. AS PER THE VIDEO SAMPLE REPORTED, IT WAS HARD TO INFUSE AND REQUIRED TOO MUCH EFFORT. THIS WAS TO VERIFY THAT THE BALLOON WAS NOT RUPTURED AND THERE WAS NO LEAK. WHEN THE USER TRIED TO REMOVE THE WATER FROM THE BALLOON OF THE PROBE, THE LIQUID DID NOT COME OUT DURING THE PREPARATION OF THE RRDY PATIENT PROCEDURE (DATE OF EVENT - 07/12/2022). THE USER TRIED TWICE MORE, BUT IT WAS NOT POSSIBLE TO REMOVE THE WATER FROM THE BALLOON OF THE PROBE DURING THE PREPARATION OF THE PATIENT'S PROCEDURE PNR (DATE OF EVENT - 07/13/2022). AS PER MAIL NOTIFICATION RECEIVED ON 25AUG2022, STATED THAT THERE WAS NO CONTACT OF THE PRODUCT WITH THE PATIENT. AS PER FOLLOW-UP INFORMATION RECEIVED ON 02SEP2022, STATED THAT THE CUSTOMER USED LUER LOCK SYRINGE AND THE HOSPITAL USED ITS OWN SYRINGE. THE CUSTOMER HAD ALREADY USED THE PRODUCT IN PREVIOUS YEARS AND STATED THAT THE PROBLEM WAS ONLY WITH CATHETERS. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 26OCT2022, IT WAS STATED THAT THE CATHETER WAS NOT USED ON THE PATIENT AND THERE WAS NO DAMAGE TO THE PATIENT. THE PROBLEM WAS IDENTIFIED BEFORE THE CATHETER WAS USED IN THE PATIENT.
IT WAS REPORTED THAT THE FOLEY CATHETERS WERE PRESENTING DIFFICULTIES WHEN VERIFYING THAT THE BALLOON WAS IN GOOD CONDITION. DURING FILLING, IT WAS VERY COMPLICATED TO INTRODUCE THE LIQUID SOLUTION (DATE OF EVENT - UNK) AND WHEN EMPTYING THE CATHETER, THE SOLUTION CAME OUT SLOWLY AND EVEN SOME PROBES REMAINED WITH THE LIQUID INSIDE WHICH NEVER EMPTIED THE LIQUID PLACED. THE BALLOON MUST BE COMPLETELY DEFLATED WHEN REMOVED FROM THE PATIENT, BECAUSE IF IT WAS NOT DEFLATED CORRECTLY THEN IT COULD GENERATE HEALTH RISKS OF GREAT IMPACT (DATE OF EVENT - UNK). IT WAS MENTIONED THAT SEVEN PROBES HAD BEEN REPORTED FROM THE SURGICAL AREA AND THEY WERE USING A 5 ML INSUFFLATION SYRINGE. AS PER THE VIDEO SAMPLE REPORTED, IT WAS HARD TO INFUSE AND REQUIRED TOO MUCH EFFORT. THIS WAS TO VERIFY THAT THE BALLOON WAS NOT RUPTURED AND THERE WAS NO LEAK. WHEN THE USER TRIED TO REMOVE THE WATER FROM THE BALLOON OF THE PROBE, THE LIQUID DID NOT COME OUT DURING THE PREPARATION OF THE RRDY PATIENT PROCEDURE (DATE OF EVENT - 07/12/2022). THE USER TRIED TWICE MORE, BUT IT WAS NOT POSSIBLE TO REMOVE THE WATER FROM THE BALLOON OF THE PROBE DURING THE PREPARATION OF THE PATIENT'S PROCEDURE PNR (DATE OF EVENT - 07/13/2022). AS PER MAIL NOTIFICATION RECEIVED ON 25AUG2022, STATED THAT THERE WAS NO CONTACT OF THE PRODUCT WITH THE PATIENT. AS PER FOLLOW-UP INFORMATION RECEIVED ON 02SEP2022, STATED THAT THE CUSTOMER USED LUER LOCK SYRINGE AND THE HOSPITAL USED ITS OWN SYRINGE. THE CUSTOMER HAD ALREADY USED THE PRODUCT IN PREVIOUS YEARS AND STATED THAT THE PROBLEM WAS ONLY WITH CATHETERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1988706 | BARDIA® FOLEY CATHETER SILICONE COATED | FOLEY CATHETER | EZC | C.R. BARD, INC. (COVINGTON) -1018233 | 123516A | MYFV1233 | 00801741095092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other |