FDA Adverse Event
Malfunction
Summary report: N
BLOOD GAS SYRINGE
MDR report key: 11915
·
Received March 9, 1994
Report
- Report Number
- MW1001017
- Event Type
- Malfunction
- Date Received
- March 9, 1994
- Report Date
- February 23, 1994
- Manufacturer
- MARQUEST MEDICAL PRODUCTS, INC.
- Product Code
- CBT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
SYRINGES HAVE CRACK IN PLASTIC BARREL WHICH LEAKS BLOOD WHEN PLUNGER IS DEPRESSED TO EXPEL SAMPLE FOR ANALYSIS. THERE WERE THREE DEFECTIVE SYRINGES IN APPROX ONE MONTH INVOLVING 2 DIFFERENT TYPES OF SYRINGES; 3 CC ASPIRATOR AND 3 CC BLOOD GAS KIT. (ALSO SEE MW1001016.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOOD GAS SYRINGE | CBT | MARQUEST MEDICAL PRODUCTS, INC. | 71585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |