FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 1.8ML MMT-326A
MDR report key: 3073704
·
Received April 23, 2013
Report
- Report Number
- 3004209178-2013-92706
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 2, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
IT IS REPORTED THAT RESERVOIR LEAKED DURING PRIMING, LEAKED PAST BOTH O-RINGS. CUSTOMER DID NOT USE THE RESERVOIR NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173443 | RESERVOIR 1.8ML MMT-326A | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-326A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |