FDA Adverse Event
Other
Summary report: N
MEDICHOICE BLOOD TRANSFER DEVICE FOR USE WITH FEMALE LUER SYRINGE
MDR report key: 18208902
·
Received November 24, 2023
Report
- Report Number
- MW5148487
- Event Type
- Other
- Date Received
- November 24, 2023
- Date of Event
- November 9, 2023
- Report Date
- November 16, 2023
- Manufacturer
- OWENS & MINOR DISTRIBUTION, INC.
- Product Code
- KST
- UDI-DI
- 10885632136764
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
HAD 3 KNOWN INSTANCES WHERE THE BLACK NEEDLE PIECE IN THE BLOOD TRANSFER DEVICE BECAME DETACHED FROM THE REST OF THE BLOOD TRANSFER DEVICE. ONE WAS SUCKED INTO A BLOOD CULTURE BOTTLE. THE OTHER TWO WERE ABLE TO BE REMOVED FROM THE BOTTLES. HOWEVER, THESE PUT PATIENTS AND PERSONNEL AT RISK TO INFECTIOUS MATERIAL, BLOOD BORNE PATHOGENS AND UNNECESSARY TREATMENT. ONE OF THE PHLEBOTOMISTS WAS SPRAYED BY BLOOD DUE TO THE FAILURE. REFERENCE REPORT #MW5148488, #MW5148489.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1218595 | MEDICHOICE BLOOD TRANSFER DEVICE FOR USE WITH FEMALE LUER SYRINGE | SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL | KST | OWENS & MINOR DISTRIBUTION, INC. | 2206DH02A | 10885632136764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |