POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY
Report
- Report Number
- 3006260740-2019-01114
- Event Type
- Malfunction
- Date Received
- April 19, 2019
- Report Date
- June 28, 2019
- Manufacturer
- BARD ACCESS SYSTEMS
- Product Code
- LJS
- UDI-DI
- 00801741028533
- PMA / PMN Number
- K063848
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
CORRECTED DATA: MDR CLASSIFICATION CHANGED TO MALFUNCTION.
THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A BROKEN CATHETER WAS CONFIRMED, AND THE CAUSE APPEARED TO BE USE-RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 5FR S/L POWERGROSHONG CATHETER. USAGE RESIDUES WERE OBSERVED THROUGHOUT THE SAMPLE. THE SAMPLE TERMINATED AT THE DISTAL END OF THE MOLDED JOINT. THE CATHETER SHAFT WAS NOT RETURNED FOR EVALUATION. MICROSCOPIC INSPECTION OF THE BREAK SITE REVEALED A COARSELY GRANULAR FRACTURE SURFACE. TACTILE INSPECTION OF THE SAMPLE REVEALED TENSILE WEAKNESS AND MATERIAL NECKING AT THE PROXIMAL END OF THE EXTENSION TUBING. THE FRACTURE FEATURES, TENSILE WEAKNESS AND NECKING SUGGESTED THAT THE CATHETER TUBING MATERIAL FAILED UNDER TENSILE (PULLING) STRESS. THE LOCATION OF THE BREAK SUGGESTED THAT CATHETER SECUREMENT AND MAINTENANCE TECHNIQUE MAY HAVE CONTRIBUTED. A LOT HISTORY REVIEW (LHR) OF RECX1506 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (RECX1506) HAVE BEEN REPORTED FROM THE SAME FACILITY IN CANADA.
IT WAS REPORTED THAT ON MARCH 10TH A CLIENT REPORTED THAT THEIR PICC HAD ALLEGEDLY "BROKEN". THEY STATED THAT IT JUST ALLEGEDLY HAPPENED, NO UNTOWARD ACTIONS HAPPENED ON THEIR PART (SCISSORS, ETC). IT WAS INSERTED AT LGH ON MARCH 4TH AND THE LOT # WAS RECX1506. PATIENT WAS SENT TO VGH ER WHERE THEY REMOVED IT (AND THREW IT AWAY SADLY) AND THE CLIENT HAD A NEW ONE INSERTED THE NEXT DAY. PATIENT OUTCOME/STATUS REPORTED AS STABLE.
IT WAS REPORTED THAT ON MARCH 10TH A CLIENT REPORTED THAT THEIR PICC HAD ALLEGEDLY "BROKEN". THEY STATED THAT IT JUST ALLEGEDLY HAPPENED, NO UNTOWARD ACTIONS HAPPENED ON THEIR PART (SCISSORS, ETC). IT WAS INSERTED AT LGH ON MARCH 4TH AND THE LOT # WAS RECX1506. PATIENT WAS SENT TO VGH ER WHERE THEY REMOVED IT (AND THREW IT AWAY SADLY) AND THE CLIENT HAD A NEW ONE INSERTED THE NEXT DAY. PATIENT OUTCOME/STATUS REPORTED AS STABLE.
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF RECX1506 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (RECX1506) HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(4).
IT WAS REPORTED THAT ON (B)(6) A CLIENT REPORTED THAT THEIR PICC HAD ALLEGEDLY "BROKEN". THEY STATED THAT IT JUST ALLEGEDLY HAPPENED, NO UNTOWARD ACTIONS HAPPENED ON THEIR PART (SCISSORS, ETC). IT WAS INSERTED AT LGH ON (B)(6) AND THE LOT # WAS RECX1506. PATIENT WAS SENT TO VGH ER WHERE THEY REMOVED IT (AND THREW IT AWAY SADLY) AND THE CLIENT HAD A NEW ONE INSERTED THE NEXT DAY. PATIENT OUTCOME/STATUS REPORTED AS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323563 | POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS | LJS | BARD ACCESS SYSTEMS | N/A | RECX1506 | 00801741028533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |