FDA Adverse Event
Malfunction
Summary report: N
VANISHPOINT® SYRINGE
MDR report key: 13714676
·
Received March 9, 2022
Report
- Report Number
- 3017368639-2022-00009
- Event Type
- Malfunction
- Date Received
- March 9, 2022
- Date of Event
- February 9, 2022
- Report Date
- March 9, 2022
- Manufacturer
- RETRACTABLE TECHNOLOGIES, INC.
- Product Code
- MEG
- UDI-DI
- 00613703101600
- PMA / PMN Number
- K980069
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
MCKESSON MEDICAL-SURGICAL, INC. IS THE ASSEMBLER OF CONVENIENCE KITS THAT CAN CONTAIN A SYRINGE COMPONENT FROM THE MANUFACTURER IDENTIFIED. THE ITEM REF # AND LOT # REPORTED AND IDENTIFIED IN SECTION D HAS BEEN CONFIRMED AS HAVING BEEN USED IN THE ASSEMBLY OF CONVENIENCE KITS SUPPLIED BY MCKESSON MEDICAL-SURGICAL, INC.. WE HAVE NOTIFIED (B)(6) AND (B)(6) FOR AWARENESS.
Description of Event or Problem · 0
CUSTOMER REPORTED THAT ON (B)(6) 2022, UPON INSPECTING THE SYRINGES, MOLD AND CONDENSATION WERE DISCOVERED INSIDE THE SEALED, PACKAGED SYRINGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167926 | VANISHPOINT® SYRINGE | 1ML 25G X 1" SYRINGE | MEG | RETRACTABLE TECHNOLOGIES, INC. | 10161 | G210842 | 00613703101600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |