FDA Adverse Event
Injury
Summary report: N
MULTI-LUMEN/PSI KIT
MDR report key: 1021253
·
Received March 28, 2008
Report
- Report Number
- 1036844-2008-00047
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- March 3, 2008
- Report Date
- March 28, 2008
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQO
- PMA / PMN Number
- K002507
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CLINICIAN THAT WHEN THE KIT WAS OPENED, THE PHYSICIAN NOTED NO OBVIOUS DEFECTS. HOWEVER, AFTER PLACING IN THE PATIENT, A SLIT WAS PRESENT AT THE PROXIMAL LUMEN AND/OR HUB WHICH CAUSED SEVERE BLEEDING FROM THE CATHETER. IT APPEARS THE DEFECT WAS PRESENT WHEN THE KIT WAS OPENED, BUT THE PHYSICIAN DID NOT NOTICE IT BEFORE INSERTION. UPDATE - NO BLOOD TRANSFUSION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LUMEN/PSI KIT | MULTI-LUMEN ACCESS CATHETERS | DQO | ARROW INTERNATIONAL INC. | RF6079460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |