FDA Adverse Event
Malfunction
Summary report: N
CURLIN INFUSION PAINSMART IOD IV PUMP
MDR report key: 1508454
·
Received October 14, 2009
Report
- Report Number
- 1722139-2009-00042
- Event Type
- Malfunction
- Date Received
- October 14, 2009
- Date of Event
- September 11, 2009
- Report Date
- October 13, 2009
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PUMP WILL NOT BE RETURNED TO MOOG MEDICAL DEVICES GROUP PER THE CUSTOMER. MOOG CLINICIAN VISITED THE CUSTOMER SITE AND PROVIDED TRAINING ON USE WITH SYRINGES.
Description of Event or Problem · 1
REPORTED BY THE CUSTOMER AS: "B-D SYRINGE IN USE. PUMP READING 14.7ML REMAINING, HOWEVER, 27ML ACTUALLY REMAINING IN SYRINGE. NURSE DENIES KNOWING ABOUT HAVING TO TWIST THE PLUNGER WHEN HANGING. DOES NOT KNOW IF NURSE WHO HUNG THE SYRINGE DID SO. MOOG CLINICIAN DISPATCHED TO THE UNIT FOR TRAINING. NO PUMP OR SYRINGE WILL BE SENT TO MOOG FOR EVALUATION." PATIENT INJURY? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN INFUSION PAINSMART IOD IV PUMP | FRN | MOOG MEDICAL DEVICES GROUP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |