FDA Adverse Event
Malfunction
Summary report: N
MULTI-LUMEN CVC KIT: 2-L 8 FR X 6IN (16C
MDR report key: 2080083
·
Received April 7, 2011
Report
- Report Number
- 1036844-2011-00111
- Event Type
- Malfunction
- Date Received
- April 7, 2011
- Date of Event
- March 22, 2011
- Report Date
- April 6, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- FOZ
- PMA / PMN Number
- K071538
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DRAPE PERFORATION TORE, WHICH CONTAMINATED THE STERILE FIELD. THIS EXPOSED THE EAR AND HAIR OF THE PT. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM THE HOSP CONTACT STATED THIS INCIDENT OCCURRED (B)(6) 2011. DURING THE PROCEDURE, THE PT WAS DRAPED AND THE PHYSICIAN HAD JUST INSERTED THE CENTRAL VENOUS CATHETER INTO THE PT'S NECK WHEN THE PERFORATION ON THE DRAPE TORE AWAY. THE PHYSICIAN COMPLETED THE PROCEDURE. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE HOSP WILL BE FOLLOWING UP WITH THEIR PT 30 DAYS POST OP. TO DATE THERE HAVE BEEN NO PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN CVC KIT: 2-L 8 FR X 6IN (16C | ARROWGARD CATHETER PRODUCTS | FOZ | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |