FDA Adverse Event
Malfunction
Summary report: N
DROPSAFE SYRINGE
MDR report key: 13714658
·
Received March 9, 2022
Report
- Report Number
- 3017368639-2022-00006
- Event Type
- Malfunction
- Date Received
- March 9, 2022
- Date of Event
- February 9, 2022
- Report Date
- March 9, 2022
- Manufacturer
- HTL-STREFA S.A.
- Product Code
- MEG
- UDI-DI
- 85907996099333
- PMA / PMN Number
- K170651
- 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. THE ITEM REF # AND LOT # REPORTED BEEN CONFIRMED AS HAVING BEEN USED IN THE ASSEMBLY OF CONVENIENCE KITS SUPPLIED BY MCKESSON MEDICAL-SURGICAL, INC.. WE HAVE NOTIFIED (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 |
|---|---|---|---|---|---|---|---|
| 167925 | DROPSAFE SYRINGE | 1ML LUER LOCK SYRINGE | MEG | HTL-STREFA S.A. | 1ML | DS010026 | 85907996099333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |