FDA Adverse Event
Malfunction
Summary report: N
ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX
MDR report key: 7000699
·
Received November 3, 2017
Report
- Report Number
- 1018233-2017-05696
- Event Type
- Malfunction
- Date Received
- November 3, 2017
- Report Date
- November 6, 2017
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- NNX
- UDI-DI
- 00801741071287
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON FURTHER REVIEW, BARD MEDICAL HAS DETERMINED THAT THIS MDR WAS INITIALLY REPORTED IN ERROR AS THIS EVENT IS NOT REPORTABLE.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS A SIZE 36MM INSTEAD OF 29MM.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS A SIZE 36MM INSTEAD OF 29MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779743 | ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 29MM 100BX | MEC | NNX | C.R. BARD, INC. (COVINGTON) -1018233 | 39102 | UNK | 00801741071287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |