FDA Adverse Event
Malfunction
Summary report: N
SINGLE LUMEN 1.9FR SILICONE PICC PROCEDURAL KIT
MDR report key: 9413466
·
Received December 4, 2019
Report
- Report Number
- 3007697249-2018-11001
- Event Type
- Malfunction
- Date Received
- December 4, 2019
- Date of Event
- October 1, 2019
- Report Date
- November 26, 2019
- Manufacturer
- FOOTPRINT MEDICAL INC.
- Product Code
- LJS
- UDI-DI
- 00858778006041
- PMA / PMN Number
- K091488
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD FOR LOT #191140 WAS REVIEWED. ALL CATHETERS PASSED IN-PROCESS AND FINAL INSPECTION CRITERIA INCLUDING LEAK TESTING. HOSPITAL STAFF CLAIM THAT THEY "DID NOT THINK IT WAS THE CATHETER ITSELF, BUT DAMAGE CAUSED BY MANIPULATION OF THE LINE AND THE PARENT PUTTING STRAIN ON IT INADVERTENTLY". BASED ON THE DHR REVIEW AND THE STATEMENT FROM (B)(6) STAFF, IT IS REASONABLE TO CONCLUDE THAT THIS IS NOT A MANUFACTURER DEFECT.
Description of Event or Problem · 1
DURING ASSESSMENT OF THE PICC, THE DRESSING APPEARED WET UNDERNEATH. MD WAS NOTIFIED AND PLACEMENT WAS VERIFIED. THE DRESSING WAS CHANGED AND THE PICC WAS NOTED TO BE LEAKING FROM THE PICC TUBING WHERE THE TUBING MEETS THE PLASTIC HEART. THE LINE WAS DISCONTINUED UPON DISCOVERY OF LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1209065 | SINGLE LUMEN 1.9FR SILICONE PICC PROCEDURAL KIT | PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | FOOTPRINT MEDICAL INC. | S1PIC1.9-S | 191140 | 00858778006041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DA |