HYDROPICC
Report
- Report Number
- 3015060232-2024-00012
- Event Type
- Injury
- Date Received
- May 24, 2024
- Date of Event
- April 27, 2024
- Report Date
- June 14, 2024
- Manufacturer
- ACCESS VASCULAR. INC.
- Product Code
- LJS
- UDI-DI
- 00850030354068
- PMA / PMN Number
- K213550
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE COMPLAINANT REPORTED THAT THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE HAD BEEN IN PLACE FOR APPROXIMATELY ONE WEEK. ON APRIL 27, 2024, THE PATIENT FACILITY REPORTED A LEAK IN THE PICC LINE. THE PATIENT ALSO REPORTED EXPERIENCING DISCOMFORT IN THEIR ARM OVER THE PAST FEW DAYS. UPON EXAMINATION, THE COMPLAINANT IDENTIFIED THAT THE CATHETER WAS TORN AT THE BASE NEAR THE SUTURE WING TIP. ALTHOUGH THE COMPLAINANT RETAINED THE CATHETER, IT HAS NOT YET BEEN RETURNED FOR INVESTIGATION. THE MANUFACTURER WILL FOLLOW UP ON THIS INITIAL REPORT ONCE THE INVESTIGATION IS COMPLETE.
AVI SUBMITTED AN INITIAL MDR (3015060232-2024-00012) PRIOR TO THE 30-DAY REPORTING REQUIREMENT. THE SUBJECT CATHETER WAS SUBSEQUENTLY RECEIVED BY AVI FOR INVESTIGATION. UPON INVESTIGATION IT WAS OBSERVED THAT THE CATHETER WAS SEVERED AT APPROXIMATELY 2.5CM FROM THE SUTURE WING TIP. THE BREAK IN THE CATHETER SHOWED NO SIGNS OF KINKS OR OTHER MATERIAL FATIGUE. THE CUT APPEARED TO BE CAUSED BY A SHARP OBJECT. THE CAUSE OF THE CUT COULD NOT BE DETERMINED.
REPORT OF A LEAK/BREAK IN A DUAL LUMEN CATHETER.
REPORT OF A LEAK/BREAK IN A DUAL LUMEN CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2320449 | HYDROPICC | CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS | LJS | ACCESS VASCULAR. INC. | PICC-251 | 00850030354068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |