POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS
Report
- Report Number
- 3006260740-2024-06914
- Event Type
- Malfunction
- Date Received
- November 22, 2024
- Date of Event
- October 29, 2024
- Report Date
- May 23, 2025
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- UDI-DI
- 00801741138973
- PMA / PMN Number
- K091324
- Removal / Correction Number
- MDS-24-5154-C
- 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 MANUFACTURER HAS RECEIVED THE SAMPLE AND IT WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.
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. 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 4 CM AND 5 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. 'C' SHAPED IMPRESSIONS LEADING INTO THE FRACTURE SITE WHICH ARE CONSISTENT WITH MATERIAL BUCKLING DUE TO MOVEMENT WHICH CAUSED THE FRACTURE EDGES TO BE PRESSED TOGETHER. REPETITIVE KINKING OF THE INDWELLING CATHETER APPEARS TO HAVE CONTRIBUTED TO THE OBSERVED SPLIT; HOWEVER, THE SPECIFIC CIRCUMSTANCES SURROUNDING HOW KINKING DEVELOPED INTO A FRACTURE WITHIN THE CATHETER TUBING WERE ULTIMATELY UNKNOWN. A MEASUREMENT OF THE CATHETER OUTER DIAMETER, INNER DIAMETER AND WALL THICKNESS WERE TAKEN. THE CATHETER WAS FOUND TO BE WITHIN SPECIFICATION. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.
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 BY THE CUSTOMER THERE IS A HOLE ABOUT 4 CM INTO THE HOSE. DISCOVERED BY LEAKING WHEN ADMINISTERING NACL. INTRODUCED 240821 DISCONTINUED 241029. CATHETER LENGTH 39 CM, SKIN LEVEL 0 CM. VENA BASILICA RIGHT UPPER ARM. ADMISSION, ETC. X-RAY IS AVAILABLE AND IT IS IN A GOOD LOCATION. X-RAY WAS DONE DUE TO ABSENCE OF BACKFLOW. ADDITIONAL INFORMATION: IT WAS REPORTED THE LEAK WAS IN THE PATIENTS VEIN, SO INTERNAL. IT IS REPLACED WITH A NEW ONE. NO HARM TO PATIENT OR STAFF OR EXPOSURE TO BODILY FLUIDS OR BLOOD.
IT WAS REPORTED BY THE CUSTOMER THERE IS A HOLE ABOUT 4 CM INTO THE HOSE. DISCOVERED BY LEAKING WHEN ADMINISTERING NACL. INTRODUCED 240821 DISCONTINUED 241029. CATHETER LENGTH 39 CM, SKIN LEVEL 0 CM. VENA BASILICA RIGHT UPPER ARM. ADMISSION, ETC. X-RAY IS AVAILABLE AND IT IS IN A GOOD LOCATION. X-RAY WAS DONE DUE TO ABSENCE OF BACKFLOW. ADDITIONAL INFORMATION: IT WAS REPORTED THE LEAK WAS IN THE PATIENTS VEIN, SO INTERNAL. IT IS REPLACED WITH A NEW ONE. NO HARM TO PATIENT OR STAFF OR EXPOSURE TO BODILY FLUIDS OR BLOOD. INFORMATION WAS RECEIVED AND FILE WERE UPDATED FOR THIS EVENT AS PART OF A FOCUS SURVEY. THE FOLLOWING DETAIL WERE PROVIDED: PICC WAS SECURED WITH STATLOCK. IT WAS USED FOR ONCOLOGY TREATMENT. THERE WAS INTERVENTION FOR OCCLUSIONS WITH THIS PICC. IT WAS USED FOR 71 DAYS. THE XRAYS TAKEN ARE NOT AVAILABLE FOR SHARING. CATHETER SITE WAS CLEANED WITH CHLORHEXIDINE SOLUTION POURED FROM A BOTTLE (5MG/ML FROM A BOTTLE). ADDITIONAL COMMENTS: "THERE IS A HOLE ABOUT 4 CM INTO THE HOSE. DISCOVERED BY LEAKING WHEN ADMINISTERING NACL. INTRODUCED 240821 DISCONTINUED 241029 CATHETER LENGTH 39 CM, SKIN LEVEL 0 CM. VENA BASILICA RIGHT UPPER ARM. ADMISSION, ETC. X-RAY IS AVAILABLE AND IT IS IN A GOOD LOCATION 20241002 X-RAY WAS DONE DUE TO ABSENCE OF BACKFLOW, TREATMENT GIVEN 20241003 AND IT WAS FINE. 20241024 NEW TREATMENTS ARE GIVEN AND AFTER THE TREATMENT THEY CAN SEE MOISTURE UNDER THE BANDAGE, BUT JUST RE-APPLY IT BECAUSE I DON'T THINK IT'S A LEAK. 20241028 THE HEALTH CENTER SEES THAT THE CATHETER IS LEAKING, AND IT IS PULLED AT THE HOSPITAL 20241029. THEN FINDS THE HOLE."
IT WAS REPORTED BY THE CUSTOMER THERE IS A HOLE ABOUT 4 CM INTO THE HOSE. DISCOVERED BY LEAKING WHEN ADMINISTERING NACL. INTRODUCED 240821 DISCONTINUED 241029. CATHETER LENGTH 39 CM, SKIN LEVEL 0 CM. VENA BASILICA RIGHT UPPER ARM. ADMISSION, ETC. X-RAY IS AVAILABLE AND IT IS IN A GOOD LOCATION. X-RAY WAS DONE DUE TO ABSENCE OF BACKFLOW. ADDITIONAL INFORMATION: IT WAS REPORTED THE LEAK WAS IN THE PATIENTS VEIN, SO INTERNAL. IT IS REPLACED WITH A NEW ONE. NO HARM TO PATIENT OR STAFF OR EXPOSURE TO BODILY FLUIDS OR BLOOD. INFORMATION WAS RECEIVED AND FILE WERE UPDATED FOR THIS EVENT AS PART OF A FOCUS SURVEY. THE FOLLOWING DETAIL WERE PROVIDED: PICC WAS SECURED WITH STATLOCK. IT WAS USED FOR ONCOLOGY TREATMENT. THERE WAS INTERVENTION FOR OCCLUSIONS WITH THIS PICC. IT WAS USED FOR 71 DAYS. THE XRAYS TAKEN ARE NOT AVAILABLE FOR SHARING. CATHETER SITE WAS CLEANED WITH CHLORHEXIDINE SOLUTION POURED FROM A BOTTLE (5MG/ML FROM A BOTTLE). ADDITIONAL COMMENTS: "THERE IS A HOLE ABOUT 4 CM INTO THE HOSE. DISCOVERED BY LEAKING WHEN ADMINISTERING NACL. INTRODUCED 240821 DISCONTINUED 241029 CATHETER LENGTH 39 CM, SKIN LEVEL 0 CM. VENA BASILICA RIGHT UPPER ARM. ADMISSION, ETC. X-RAY IS AVAILABLE AND IT IS IN A GOOD LOCATION. ON (B)(6) 2024, X-RAY WAS DONE DUE TO ABSENCE OF BACKFLOW, TREATMENT GIVEN (B)(6) 2024 AND IT WAS FINE. ON (B)(6) 2024, NEW TREATMENTS ARE GIVEN AND AFTER THE TREATMENT THEY CAN SEE MOISTURE UNDER THE BANDAGE, BUT JUST RE-APPLY IT BECAUSE I DON'T THINK IT'S A LEAK. ON (B)(6) 2024, THE HEALTH CENTER SEES THAT THE CATHETER IS LEAKING, AND IT IS PULLED AT THE HOSPITAL (B)(6) 2024. THEN FINDS THE HOLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2602006 | POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TPS | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | C.R. BARD, INC. (BASD) -3006260740 | N/A | REJQ0393 | 00801741138973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |