FDA Adverse Event
Malfunction
Summary report: N
CATH PKGD: BERMAN 5 FR 5 0CM
MDR report key: 2171456
·
Received June 30, 2011
Report
- Report Number
- 2242445-2011-00088
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 18, 2011
- Report Date
- June 29, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQO
- PMA / PMN Number
- PREAMENDMENT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVENT OCCURRED IN THE CATH LAB. WHILE INJECTING A SECOND DYE USING A SYRINGE, A PORTION OF THE CATHETER OUTSIDE THE BODY HAD BURST. AS A RESULT, THE CATHETER WAS REMOVED AND A NEW KIT WAS OPENED AND USED WITH SUCCESS. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THERAPY WAS NOT DELAYED OR INTERRUPTED. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. THE PATIENT'S OUTCOME IS GOOD. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM (B)(6) STATED "THE SYRINGE USED WAS A 20-25CC SYRINGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CATH PKGD: BERMAN 5 FR 5 0CM | BERMAN ANGIOGRAPHIC CATHETER PRODUCTS | DQO | ARROW INTL., INC. | MF0074100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |