FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2101741
·
Received May 10, 2011
Report
- Report Number
- 6000030-2011-03389
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE HCP WAS ABLE TO ASPIRATE, BUT UNABLE TO FILL THE RESERVOIR. THE HCP ASPIRATED THE CORRECT AMOUNT OF DRUG FROM THE PUMP AND BUBBLES WERE SEEN. THE REFILL KIT TUBING WAS PATENT. THERE WAS NO NEEDLE DEPTH ISSUE. THE HCP FELT THE SILICONE RUBBER SEPTUM. THE NEEDLE WAS PATENT. THE HCP WAS ATTEMPTING TO FILL THE RESERVOIR WITH PRESERVATIVE-FREE NORMAL SALINE. THE PUMP CONTAINED DILAUDID AND BUPIVACAINE. THERE WAS NO DRUG THERAPY OR MEDICAL PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention | CATHETER: MODEL 8596, LOT # B003916N32| CATHETER: MODEL 8731, LOT # B009449N13| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT # B009449N13| CATHETER: MODEL 8596, LOT # B003916N32| EXPLANTED: |