FDA Adverse Event
Malfunction
Summary report: N
MCKESSON
MDR report key: 19266417
·
Received May 8, 2024
Report
- Report Number
- 3005405146-2024-00021
- Event Type
- Malfunction
- Date Received
- May 8, 2024
- Date of Event
- April 27, 2023
- Report Date
- May 7, 2024
- Manufacturer
- SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD
- Product Code
- FMF
- PMA / PMN Number
- K112057
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
UPON RECEIPT OF THE CUSTOMER COMPLAINT, KDL CONDUCTED AN INVESTIGATION THAT INCLUDED RETAINED SAMPLE TESTING AND PROCESS REVIEW. CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED IN A TIMELY MANNER IN ACCORDANCE WITH RELEVANT REGULATIONS AND COMPANY DOCUMENTS TO PREVENT RECURRENCE OF THE PROBLEM.MAINTAIN COMPLAINT FILES IN ACCORDANCE WITH 21CFR PART 803.18.
Description of Event or Problem · 0
THE NEW MCK BRAND SYRINGES ARE NOT WORKING WITH THE ANTIGENS THEY USE. THE ANTIGENS ARE THICK SO WHEN THEY DRAW UP THE NEEDLE IS BREAKING/BENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146279 | MCKESSON | SYRINGE | FMF | SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUPCO.,LTD | ALLERGIST TRAY, 1CC 27GX1/2" |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |