FDA Adverse Event
Injury
Summary report: N
MONOJECT BLOOD COLLECTION NEEDLES
MDR report key: 52896
·
Received November 27, 1996
Report
- Report Number
- 1017768-1996-00011
- Event Type
- Injury
- Date Received
- November 27, 1996
- Date of Event
- July 24, 1996
- Report Date
- October 28, 1996
- Manufacturer
- SHERWOOD DAVIS AND GECK
- Product Code
- JKA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING INDICATES THAT WHEN THE LABEL INSTRUCTIONS ARE FOLLOWED, FEW PLASTIC PIECES ARE GENERATED. ALSO, IF ANY ARE GENERATED THEY ARE DIRECTED AWAY FROM THE FACE OF THE USER (AND PATIENT). THE CUSTOMER REPORTED THEY WERE NOT USING THE PRODUCT ACCORDING TO THE PRODUCT INSTRUCTIONS. THE MFG PLANT HAS AN ONGOING PROGRAM TO IMPROVE THE HEAT SEAL CHARACTERISTICS OF BLOOD COLLECTION NEEDLES. REFERENCE MFR COMPLAINT #D96-10-28-255. SECTION D - LOT NUMBERS REPORTED BY CUSTOMER 241544, 241299, 241890.
Description of Event or Problem · 1
WHEN THE ASSOCIATE WAS SEEN FOR A RE-CHECK ON THE FOLLOWING DAY (7-25-96) THE EYE WAS FEELING BETTER. THERE WAS NO INFECTION OF THE CONJUNCTIVE NOTED AN NO UPTAKE OF THE FLUORESCEIN DYE WAS NOTED. THE ASSOCIATE WAS RETURNED TO REGULAR DUTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOJECT BLOOD COLLECTION NEEDLES | BLOOD COLLECTION NEEDLE | JKA | SHERWOOD DAVIS AND GECK | NA | SEE H-10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |