BARDIA 2 WAY MALE 10CC PTFE COATED FOLEY CATHETER, 14 FR.
Report
- Report Number
- 1018233-2016-01898
- Event Type
- Injury
- Date Received
- December 29, 2016
- Report Date
- March 21, 2017
- Manufacturer
- BARD SDN. BHD. -8040607
- Product Code
- EZC
- PMA / PMN Number
- K910846
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. - 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.
RECEIVED 1 USED FOLEY CATHETER. THE REPORTED EVENT WAS CONFIRMED; HOWEVER, THE CAUSE IS UNKNOWN. THE VISUAL INSPECTION NOTED IRREGULAR BALLOON BURST. NO PIECES OF SAC WERE MISSING AND OBSERVED WEAK SPOT. DURING THE FUNCTIONAL EVALUATION, INTRODUCED WATER INTO THE INFLATION LUMEN AND DID NOT EXPERIENCE ANY OBSTRUCTIONS TO IMPEDE FLOW. MICROSCOPIC EXAMINATION FOUND NO CONDITIONS THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX." (B)(4). 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
IT WAS REPORTED THAT AFTER PLACING THE DEVICE, IT WAS NOTED THAT THE BALLOON BURST INSIDE OF THE PATIENT'S BLADDER. IT WAS ALSO REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED AN INTRAMURAL HEMATOMA OF THE BLADDER. A CYSTOSCOPY CONFIRMED THE ABSENCE OF DEBRIS IN THE BLADDER.
IT WAS REPORTED THAT AFTER PLACING THE DEVICE, IT WAS NOTED THAT THE BALLOON BURST INSIDE OF THE PATIENT'S BLADDER. IT WAS ALSO REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED THE FORMATION OF A HEMATOMA WITHIN THEIR BLADDER. A CYSTOSCOPY CONFIRMED THE ABSENCE OF DEBRIS IN THE BLADDER.
IT WAS REPORTED THAT AFTER PLACING THE DEVICE, IT WAS NOTED THAT THE BALLOON BURST INSIDE OF THE PATIENT'S BLADDER. IT WAS ALSO REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED THE FORMATION OF A HEMATOMA WITHIN THEIR BLADDER. A CYSTOSCOPY CONFIRMED THE ABSENCE OF DEBRIS IN THE BLADDER.
IT WAS REPORTED THAT AFTER PLACING THE DEVICE, IT WAS NOTED THAT THE BALLOON BURST INSIDE OF THE PATIENT'S BLADDER. IT WAS ALSO REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED AN INTRAMURAL HEMATOMA OF THE BLADDER. A CYSTOSCOPY CONFIRMED THE ABSENCE OF DEBRIS IN THE BLADDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863633 | BARDIA 2 WAY MALE 10CC PTFE COATED FOLEY CATHETER, 14 FR. | BARDIA PFTE | EZC | BARD SDN. BHD. -8040607 | 6AA8033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |