BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2023-02279
- Event Type
- Malfunction
- Date Received
- April 4, 2023
- Date of Event
- February 21, 2023
- Report Date
- April 24, 2023
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- MJC
- UDI-DI
- 00801741039843
- PMA / PMN Number
- K070582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 REPORTED EVENT WAS CONFIRMED AND THE CAUSE WAS UNKNOWN. ALTHOUGH A SPECIFIC CAUSE CANNOT BE DETERMINED, BASED ON THE RISK DOCUMENT A POTENTIAL ROOT CAUSE FOR THIS EVENT COULD BE IMPERFECTION IN BALLOON DUE TO PROCESS. 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: "[WARNINGS]: METHOD FOR USE: DO NOT INFLATE THE BALLOON IN THE URETHRA. [THE URETHRA MAY BE INJURED.] DO NOT PULL THE CATHETER HARD. [THE BLADDER/URETHRA MAY BE INJURED.] APPLICABLE PATIENTS: PATIENTS WITH DELIRIUM WHO MIGHT PULL OUT CATHETER [WHEN PATIENT TUGS AT CATHETER UNCONSCIOUSLY, THE BLADDER AND URETHRA MAY BE DAMAGED.] [CONTRAINDICATIONS]: METHOD FOR USE: DO NOT REUSE. DO NOT RESTERILIZE. THIS DEVICE CONTAINS 10% POVIDONE-IODINE. FOR PATIENTS WITH PAST HISTORY OF ALLERGIC HYPERSENSITIVITY TO POVIDONE-IODINE OR IODINE, CONSIDER USING ALTERNATIVE DISINFECTANTS. BE CAREFUL THAT THE CATHETER IS NOT EXPOSED TO OINTMENTS, CONTRAST MEDIUM OR OIL-BASED LUBRICANTS (INCLUDING VEGETABLE OILS SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS). [THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON.] DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. AVOID CONTACT WITH ANY BLADES OR SHARP-EDGED INSTRUMENTS. [CATHETER DAMAGE MAY CAUSE BALLOON RUPTURE AND ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.] APPLICABLE PATIENTS: PATIENTS WITH KNOWN ALLERGY TO SILVER COATED CATHETER" 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.
IT WAS REPORTED THAT THERE WERE NO ABNORMALITIES IN THE EXPANSION OF THE BALLOON BEFORE INSERTION, BUT AFTER INSERTION INTO THE PATIENT, THE BALLOON WAS DAMAGED AND SPONTANEOUS WITHDRAWAL OCCURRED FOUR TIMES. ALL THE EVENT WAS CONFIRMED WITH THE SAME LOT AND THE REMAINING ONE WAS COLLECTED WITHOUT BEING USED. THE USER THEN USED 29030J14 DUE TO THE LACK OF 119314. SIMILARLY, THERE WAS A REPORT DRAFTED SEPARATELY FOR SPONTANEOUS WITHDRAWAL DUE TO BALLOON DAMAGE. PER INVESTIGATOR NOTIFICATION RECEIVED VIA EMAIL ON 12-MAR-2023 STATED THAT PER SAMPLES RECEIVED. 8 SAMPLES WERE RETURNED. 4 SAMPLES NOT IN PACKAGING APPEARED TO BE USED WITH MATERIAL NUMBER 119314 AND MANUFACTURING LOT NUMBER NGGS2164. 4 SAMPLES IN UNOPENED PACKAGING WITH MATERIAL NUMBER 119314, 3 WITH BATCH NUMBER NGGT3722, AND 1 WITH BATCH NUMBER NGGS3548. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 15-MAR-2023, STATED THAT THERE WAS NO BALLOON RUPTURE. THE CATHETER HAD A BALLOON PINHOLE.
IT WAS REPORTED THAT THERE WERE NO ABNORMALITIES IN THE EXPANSION OF THE BALLOON BEFORE INSERTION, BUT AFTER INSERTION INTO THE PATIENT, THE BALLOON WAS DAMAGED AND SPONTANEOUS WITHDRAWAL OCCURRED FOUR TIMES. ALL THE EVENT WAS CONFIRMED WITH THE SAME LOT AND THE REMAINING ONE WAS COLLECTED WITHOUT BEING USED. THE USER THEN USED 29030J14 DUE TO THE LACK OF 119314. SIMILARLY, THERE WAS A REPORT DRAFTED SEPARATELY FOR SPONTANEOUS WITHDRAWAL DUE TO BALLOON DAMAGE. PER INVESTIGATOR NOTIFICATION RECEIVED VIA EMAIL ON 12-MAR-2023 STATED THAT PER SAMPLES RECEIVED. 8 SAMPLES WERE RETURNED. 4 SAMPLES NOT IN PACKAGING APPEARED TO BE USED WITH MATERIAL NUMBER 119314 AND MANUFACTURING LOT NUMBER NGGS2164. 4 SAMPLES IN UNOPENED PACKAGING WITH MATERIAL NUMBER 119314, 3 WITH BATCH NUMBER NGGT3722, AND 1 WITH BATCH NUMBER NGGS3548. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 15-MAR-2023, STATED THAT THERE WAS NO BALLOON RUPTURE. THE CATHETER HAD A BALLOON PINHOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1130262 | BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER (SILICONE) | MJC | C.R. BARD, INC. (COVINGTON) -1018233 | 119314 | NGGS2164 | 00801741039843 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |