ROCHESTER INTERMITTENT MAGIC3 HYDRO 16 FEMALE 30BX
Report
- Report Number
- 1018233-2016-01794
- Event Type
- Malfunction
- Date Received
- December 13, 2016
- Report Date
- October 27, 2017
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KOD
- PMA / PMN Number
- K000723
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
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.
RECEIVED 51 UNOPENED MAGIC 3 CATHETERS WITH 3 OF THE BOXES' PACKAGINGS. THE REPORTED ISSUE WAS CONFIRMED; HOWEVER, THE CAUSE IS UNKNOWN. PER VISUAL INSPECTION, NO DEFECTS WERE FOUND IN THE SAMPLE. PER FUNCTIONAL EVALUATION, THE SAMPLES DID NOT PASS THE PERFORMED LUBRICITY TEST. 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: "INTENDED USE: THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PATIENTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. PLEASE CONTACT YOUR PHYSICIAN TO DETERMINE WHICH PRODUCT OPTIONS ARE BEST FOR YOU, PAYING CLOSE ATTENTION TO PRODUCT WARNINGS/ PRECAUTIONS AND ADVERSE REACTIONS. THE CATHETER BECOMES SLIPPERY WHEN WETTED WITH WATER, ELIMINATING THE NEED FOR A SEPARATE LUBRICANT. FOR YOUR ADDED CONVENIENCE, THIS CATHETER IS PACKAGED WITH ITS OWN STERILE WATER. SIMPLY RELEASE THE WATER FROM ITS FOIL PACKET AND THEN TIP THE UN-OPENED CATHETER PACKAGE END-TO-END. THE CATHETER ACTS LIKE A MAGNET TO ATTRACT THE WATER AND ACTIVATE ITS SLIPPERY COATING. FOLLOW THESE STEPS FOR BEST RESULTS. RELEASE THE WATER PRIOR TO OPENING THE SEALED CATHETER POUCH: APPLY PRESSURE TO THE FOIL PACKET TO RELEASE THE WATER. ENSURE ALL WATER IS RELEASED FROM THE FOIL PACKET. WET THE CATHETER. HOLD PACKAGE WITH PRINTED SIDE UP. TIP PACKAGE END-TO-END THREE TO SIX TIMES TO WET CATHETER. THIS MOVEMENT IS REQUIRED SO THAT THE WATER TRANSFERS BACK AND FORTH OVER THE CATHETER TO FULLY WET THE HYDROPHILIC COATING. USE THE CATHETER. PEEL BACK PACKAGE TO EXPOSE FUNNEL END OF CATHETER. IF DESIRED, USE THE SELF-ADHESIVE TAPE ON THE PACKAGE TO TEMPORARILY ATTACH THE POUCH TO ANY DRY VERTICAL SURFACE. REMOVE CATHETER AND USE ACCORDING TO PHYSICIAN¿S INSTRUCTIONS. WARNING: THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE, DO NOT RESTERILIZE. MADE OF SILICONE ELASTOMER." (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.
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.
IT WAS REPORTED THAT DEVICE LACKED LUBRICITY. THE COMPLAINANT STATED THAT AFTER THE WATER PACKET WAS ACTIVATED AND THE CATHETER WAS COATED, THE LUBRICIOUS COATING WAS IN EXCESS, AND DID NOT STICK TO THE CATHETER. AS A RESULT, THE COMPLAINANT'S ATTEMPTED TO INSERT THE CATHETER WAS UNSUCCESSFUL. SUBSEQUENTLY, A NEW CATHETER WAS INSERTED AND THE URINE DRAINED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
IT WAS REPORTED THAT DEVICE LACKED LUBRICITY. THE COMPLAINANT STATED THAT AFTER THE WATER PACKET WAS ACTIVATED AND THE CATHETER WAS COATED, THE LUBRICIOUS COATING WAS ALLEGEDLY IN EXCESS, AND DID NOT STICK TO THE CATHETER. CONSEQUENTLY, THE COMPLAINANT'S ATTEMPT TO INSERT THE CATHETER WAS UNSUCCESSFUL. SUBSEQUENTLY, A NEW CATHETER WAS INSERTED AND THE URINE DRAINED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
IT WAS REPORTED THAT DEVICE LACKED LUBRICITY. THE COMPLAINANT STATED THAT AFTER THE WATER PACKET WAS ACTIVATED AND THE CATHETER WAS COATED, THE LUBRICIOUS COATING WAS ALLEGEDLY IN EXCESS, AND DID NOT STICK TO THE CATHETER. CONSEQUENTLY, THE COMPLAINANT'S ATTEMPT TO INSERT THE CATHETER WAS UNSUCCESSFUL. SUBSEQUENTLY, A NEW CATHETER WAS INSERTED AND THE URINE DRAINED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
IT WAS REPORTED THAT DEVICE LACKED LUBRICITY. THE COMPLAINANT STATED THAT AFTER THE WATER PACKET WAS ACTIVATED AND THE CATHETER WAS COATED, THE LUBRICIOUS COATING WAS IN EXCESS, AND DID NOT STICK TO THE CATHETER. AS A RESULT, THE COMPLAINANT'S ATTEMPTED TO INSERT THE CATHETER WAS UNSUCCESSFUL. SUBSEQUENTLY, A NEW CATHETER WAS INSERTED AND THE URINE DRAINED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
IT WAS REPORTED THAT DEVICE LACKED LUBRICITY. THE COMPLAINANT STATED THAT AFTER THE WATER PACKET WAS ACTIVATED AND THE CATHETER WAS COATED, THE LUBRICIOUS COATING WAS ALLEGEDLY IN EXCESS, AND DID NOT STICK TO THE CATHETER. CONSEQUENTLY, THE COMPLAINANT'S ATTEMPT TO INSERT THE CATHETER WAS UNSUCCESSFUL. SUBSEQUENTLY, A NEW CATHETER WAS INSERTED AND THE URINE DRAINED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 823176 | ROCHESTER INTERMITTENT MAGIC3 HYDRO 16 FEMALE 30BX | MAGIC 3 CATHETER | KOD | C.R. BARD, INC. (COVINGTON) -1018233 | JUAT0991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |