FDA Adverse Event
Other
Summary report: N
3-0 SILK BLACK BRAIDED SUTURE
MDR report key: 553254
·
Received February 2, 2004
Report
- Report Number
- 553254
- Event Type
- Other
- Date Received
- February 2, 2004
- Date of Event
- January 20, 2004
- Report Date
- February 2, 2004
- Manufacturer
- *
- Product Code
- GAP
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
NEEDLE COUNT ON CLOSING DIFFERED FROM RECORDED NUMBER OF NEEDLES OPENED ON BACK TABLE. THE NEEDLE COUNT EQUALED THE NUMBER OF NEEDLE PACKS BUT NOT THE NUMBER OF NEEDLES. THE PATIENT WAS X-RAYED. THERE WERE NO NEEDLES IDENTIFIED IN THE PATIENT. THE SINGLE PACK LOOKS LIKE THE MULTI PACK. RPTR HAS SEPARATED THE TWO PACKS THAT LOOK ALIKE SO A PERSON WILL NOT GRAB ONE THINKING IT WAS THE OTHER. THEY WERE STORED SIDE BY SIDE. LIKEWISE, RPTR ALSO FOUND SINGLES WITH THE MULTI AND MULTI WITH THE SINGLES. THE PROCESS FOR OPENING AND COUNTING EACH NEEDLE WITH THE CIRCULATOR AND SCRUB NURSE HAS BEEN RE-INSERVICED. TRAINING AND STORAGE ARE TWO PROCESS ISSUES BUT PACKAGING DIFFERENT WOULD ALSO BE HELPFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3-0 SILK BLACK BRAIDED SUTURE | SUTURE | GAP | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |