POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F FULL TRAY
Report
- Report Number
- 3006260740-2024-01992
- Event Type
- Injury
- Date Received
- May 1, 2024
- Date of Event
- March 26, 2024
- Report Date
- July 9, 2024
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- PMA / PMN Number
- K091324
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.
IT WAS REPORTED BY CUSTOMER THAT, "WE HAD AN ISSUE WITH A THE ECG WIRES NOT CONNECTING PROPERLY TO THE SHERLOCK ON (B)(6) 2024. I ATTACHED THE WIRES THAT CAME WITH THE PICC KIT THE SHERLOCK AT THE BEGINNING OF MY PROCEDURE AND HAD A GOOD EXTERNAL ECG READING. I CONTINUED THOUGHT THE PROCEDURE AND HAD THE READING OF MY LOLLY POP SHOW UP ON THE 3CG MACHINE BUT NO INTERNAL 3CG READING. I CHECKED FOR BLOOD RETURN WHICH WAS POSITIVE THEN I FLUSHED THE LINE. STILL NO READING. I REATTACHED IN A DIFFERENT SECTION THROUGH THE STERILE DRAPE. I CONTINUED TO HAVE EXTERNAL ECG BUT NOT INTERNAL. I HAD MY COWORKER DIRECTLY ATTACH UNDER THE STERILE DRAPE WHICH ALSO DID NOT WORK. WE HAD TO OPEN ANOTHER PICC KIT TO GET THE WIRES IN ORDER TO CONTINUE WITH THE PROCEDURE. SHE REACHED UNDER THE STERILE DRAPE AND SWITCHED OUT THE WIRES WHICH INSTANTLY PRODUCED AN INTERNAL READING. THE 3CG CONFIRMED THE PICC TO BE AT DISTAL SVC, CLOSE TO THE CAJ AS THE P WAVES INCREASED BUT NO DEFLECTION AND NO CHANGE TO GREEN LOLLY POP. UNFORTUNATELY, LATER IN THAT SHIFT THE PATIENT HAD SVT LEADING TO A STAT X RAY WHICH SHOWED PICC PROJECTED OVER THE RIGHT ATRIUM AND THEY SENT THAT PATIENT TO IR FOR A PICC EXCHANGE."
IT WAS REPORTED BY CUSTOMER THAT, "WE HAD AN ISSUE WITH A THE ECG WIRES NOT CONNECTING PROPERLY TO THE SHERLOCK ON (B)(6) 2024. I ATTACHED THE WIRES THAT CAME WITH THE PICC KIT THE SHERLOCK AT THE BEGINNING OF MY PROCEDURE AND HAD A GOOD EXTERNAL ECG READING. I CONTINUED THOUGHT THE PROCEDURE AND HAD THE READING OF MY LOLLY POP SHOW UP ON THE 3CG MACHINE BUT NO INTERNAL 3CG READING. I CHECKED FOR BLOOD RETURN WHICH WAS POSITIVE THEN I FLUSHED THE LINE. STILL NO READING. I REATTACHED IN A DIFFERENT SECTION THROUGH THE STERILE DRAPE. I CONTINUED TO HAVE EXTERNAL ECG BUT NOT INTERNAL. I HAD MY COWORKER DIRECTLY ATTACH UNDER THE STERILE DRAPE WHICH ALSO DID NOT WORK. WE HAD TO OPEN ANOTHER PICC KIT TO GET THE WIRES IN ORDER TO CONTINUE WITH THE PROCEDURE. SHE REACHED UNDER THE STERILE DRAPE AND SWITCHED OUT THE WIRES WHICH INSTANTLY PRODUCED AN INTERNAL READING. THE 3CG CONFIRMED THE PICC TO BE AT DISTAL SVC, CLOSE TO THE CAJ AS THE P WAVES INCREASED BUT NO DEFLECTION AND NO CHANGE TO GREEN LOLLY POP. UNFORTUNATELY LATER IN THAT SHIFT THE PATIENT HAD SVT LEADING TO A STAT X RAY WHICH SHOWED PICC PROJECTED OVER THE RIGHT ATRIUM AND THEY SENT THAT PATIENT TO IR FOR A PICC EXCHANGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865568 | POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS STYLET 5F FULL TRAY | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REHX2301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |