FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 2935846
·
Received January 22, 2013
Report
- Report Number
- 1036844-2013-00021
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- October 3, 2012
- Report Date
- January 17, 2013
- Manufacturer
- ARROW INTL.
- Product Code
- FOZ
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SAMPLE WILL NOT BE RETURNED.
Description of Event or Problem · 1
INFO WAS RECEIVED VIA MAUDE EVENT REPORT. THE MD SUGGESTED THAT THERE MAY BE A CRACK SOMEWHERE IN THE CATHETER OF THE RIGHT SUBCLAVIAN QUAD LUMEN CENTRAL LINE SINCE THERE WAS AN INCREASE IN SERIOUS DRAINAGE COMING FROM THE INSERTION SITE WITH UPWARD TITRATION OF PHENYLEPHRINE WITHOUT POSITIVE RESPONSE IN PT'S BLOOD PRESSURE. CATHETER WAS DESCRIBED AS 8.5 FR. 4-LUMEN 20 CM. ON (B)(6) 2013 - F/U INFO FROM RISK MGMT STATES THEY DO NOT KNOW IF THEY EXCHANGED THE CATHETER FOR THE PT WHILE IN USE. THERE WERE NO DELAYS IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED. THE USED CATHETER IS RETAINED BY RISK MGMT AND WILL NOT BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31656 | NA | ADULT MULTI-LUMEN CATHETER PRODUCTS | FOZ | ARROW INTL. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |