FDA Adverse Event
Malfunction
Summary report: N
ULTIBET INSULIN SYRINGE 30G HALF CC
MDR report key: 3031259
·
Received April 5, 2006
Report
- Report Number
- 3003496248-2006-00001
- Event Type
- Malfunction
- Date Received
- April 5, 2006
- Date of Event
- February 27, 2006
- Report Date
- March 29, 2006
- Manufacturer
- BOCA MEDICAL PRODUCTS, INC. (PRIVATE LABEL)
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFG PROCESS REVIEW AND PRODUCTION RECORDS REVIEWED BY MFG SITE. (REVIEW OF THE AFFECTED LOT).
Description of Event or Problem · 1
CUSTOMER COMPLAINT THAT NEEDLES ARE BENT BEFORE USE AND SNAPS. PROTECTIVE CAP IS OFF THE SYRINGE. PT SAID THAT NEEDLE COULD CONTAMINATE THE INSULIN SOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTIBET INSULIN SYRINGE 30G HALF CC | NONE | FMF | BOCA MEDICAL PRODUCTS, INC. (PRIVATE LABEL) | NA | 5GEX1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |