FDA Adverse Event
Injury
Summary report: N
NEEDLE 24G X 6MM HI-FLO SUBQ
MDR report key: 11874806
·
Received May 24, 2021
Report
- Report Number
- MW5101518
- Event Type
- Injury
- Date Received
- May 24, 2021
- Report Date
- May 17, 2021
- Manufacturer
- REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
- Product Code
- FMI
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT WANTED TO DISCUSS LEAKING WITH HER LAST FEW INFUSIONS. PT DOES ULTIMATE /ROTATE SITES BETWEEN HER ABDOMEN & THIGHS. REVIEWED APPROPRIATE AND SUGGESTED AREAS FOR SQ INFUSIONS. PT DESCRIBED LEAKING MORE AT THE END OF THE INFUSION ONCE SHE REMOVES THE NEEDLE AND APPEARS THAT IT IS LEAKING FROM THE PLASTIC, NOT ALWAYS THE NEEDLE ITSELF. SUGGESTED PT CAN TRY A DIFFERENT BRAND OF NEEDLE SET TO SEE IF IT WAS JUST THAT BATCH OF NEEDLE SET TUBING. PT AGREED. INDICATION: CHRONIC INFLAMMATORY DEMYELINATING POLYNEURITIS. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 765373 | NEEDLE 24G X 6MM HI-FLO SUBQ | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS | UNK | ||
| 765374 | TUBING FREEDOM 60 IV SET | PUMP, INFUSION | FRN | REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |