FDA Adverse Event
Malfunction
Summary report: N
PI PICC KIT: 4 FR X 50 CM
MDR report key: 3202099
·
Received June 27, 2013
Report
- Report Number
- 1036844-2013-00220
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- May 20, 2013
- Report Date
- June 27, 2013
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- LJS
- PMA / PMN Number
- K061289
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN ATTEMPTING TO PEEL THE SHEATH APART AFTER THE PICC WAS INSERTED THE ORANGE HANDLES ON THE TOP PART OF THE SHEATH RIPPED APART FROM THE REST OF THE SHEATH. THIS OCCURRED IN THE SPECIAL PROCEDURES ROOM. THE INSERTING NURSE WAS ABLE TO REMOVE WHAT WAS LEFT OF THE SHEATH FROM THE PT'S INSERTION SITE USING FORCEPS. THE CATHETER WAS PLACED SUCCESSFULLY. THERE WAS NO DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291819 | PI PICC KIT: 4 FR X 50 CM | PERIPHERALLY INSERTED CENTRAL CATHETERS | LJS | ARROW INTERNATIONAL INC | RF2111181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |