POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY
Report
- Report Number
- 3006260740-2024-03847
- Event Type
- Malfunction
- Date Received
- July 17, 2024
- Date of Event
- June 24, 2024
- Report Date
- November 21, 2024
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- PMA / PMN Number
- K091324
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- 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. THE COMPLAINT OF A LEAK WAS CONFIRMED AND DETERMINED TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SL POWERPICC SOLO CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A SPLIT WAS OBSERVED IN THE CATHETER TUBING BETWEEN THE 5 CM AND 6 CM DEPTH MARKERS. THE CATHETER SPLIT CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED. FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR. OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING). AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. THE DAMAGE LOCATION SUGGESTED THAT CATHETER SECUREMENT, ACCESS AND MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.
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.
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.
IT WAS REPORTED, THE PATIENT HAS RECEIVED 4 COURSES OF CYTOSTATICS IN HIS PICC LINE AND THE RUPTURE WAS DISCOVERED THROUGH A LEAK FROM THE INSERTION SITE IN CONNECTION WITH COURSE 5 240624. THE CATHETER WAS REMOVED. PATIENT ARE OK, ARE PLANNED FOR A NEW PICC LINE. NO EXPOSURE TO BLOOD OR BODILY FLUIDS. NO OTHER INFORMATION WAS PROVIDED.
IT WAS REPORTED, THE PATIENT HAS RECEIVED 4 COURSES OF CYTOSTATICS IN HIS PICC LINE AND THE RUPTURE WAS DISCOVERED THROUGH A LEAK FROM THE INSERTION SITE IN CONNECTION WITH COURSE 5 240624. THE CATHETER WAS REMOVED. PATIENT ARE OK, ARE PLANNED FOR A NEW PICC LINE. NO EXPOSURE TO BLOOD OR BODILY FLUIDS. NO OTHER INFORMATION WAS PROVIDED.
IT WAS REPORTED, THE PATIENT HAS RECEIVED 4 COURSES OF CYTOSTATICS IN HIS PICC LINE AND THE RUPTURE WAS DISCOVERED THROUGH A LEAK FROM THE INSERTION SITE IN CONNECTION WITH COURSE (B)(4). THE CATHETER WAS REMOVED. PATIENT ARE OK, ARE PLANNED FOR A NEW PICC LINE. NO EXPOSURE TO BLOOD OR BODILY FLUIDS. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FOR THIS EVENT AS PART OF A FOCUS SURVEY. THE FOLLOWING ADDITIONAL DETAIL WAS PROVIDED: TOTAL CATHETER LENGTH 37CM, INSERTED TO BASILIC VEIN, EXIT SITE MARKING 1CM, SECURED WITH STATLOCK. USED FOR ONCOLOGY TREATMENT (DOCEOTAXEL). THERE WAS AN OCCLUSION WITH THIS PICC, (B)(6) 2024 HARD TO FLUSH BUT THEN THE PATIENT TURNS ON LEFT SIDE THE PICCLINE WORKS FINE. (B)(6) 2024 VERY LOCATION DEPENDENT. IF YOU CHANGE THE POSITION OF THE PATIENT, YOU GET BACKFLOW. BUT COMPLETELY STOPPED IN CERTAIN POSITIONS ON PATIENT 0. THE CATHETER HAS COME OUT ABOUT 0.5 CM. CAN PROVIDE THE TREATMENT AND FLUSHES WITH NACL. (B)(6) 2024 THE PATIENT IS BEING RESCHEDULED AND THEN COMPLAINS THAT IT STINGS A LITTLE INSIDE THE ARM. BUT ACCORDING TO THE NURSE, IT LOOKS OK ON THE OUTSIDE. THE CATHETER MAY REMAIN. LEAKAGE WAS IDENTIFIED BY VISIBLE HOLE/FRACTURE OUTSIDE THE PATIENT (AT EXIT SITE OR ON EXTERNAL PART OF PICC); THE HOLE WAS INSIDE THE PATIENT. THE SALINE ARE COMING OUT FROM THE INSERTION SITE. THEY PULLED THE PICCLINE OUT AND CAN SEE A HOLE ON IT. LIKE IT HAS BEEN KINKED. PICC WAS USED FOR AROUND 90 DAYS. NO XRAYS ARE AVAILABLE. CATHETER SITE WAS CLEANED WITH CHLORHEXIDINE SOLUTION POURED FROM A BOTTLE (CHLORHEXIDIN 250ML BOTTLE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 362577 | POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F FULL TRAY | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REGX1782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |