N
Patient 1
MAUDE MDR 6360201
- MDR report key
- 6360201
- Report number
- 6360201
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-06
- Date received
- 2017-02-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LIFESHIELD | IV TUBING EXTENSION | HOSPIRA, INC. | FPK | 66132NS | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-27 | 0 |
Event Narratives#
D
Patient 1
IV THERAPY NURSE REPORTS THAT PATIENT WAS BEING ASSESSED FOR NEW PIV SITE IN THE RIGHT ARM. NO CURRENT PERIPHERAL IV'S OR MEDICATIONS INFUSING IN THE RIGHT UPPER EXTREMITY. ACCESSED VEIN IN RIGHT FOREARM WITHOUT DIFFICULTY WITH #22 GAUGE ANGIO. ATTACHED NEWLY OPENED SALINE LOCK, ASPIRATED BLOOD AND FLUSHED WITH 10 ML NS. SALINE LOCK WAS IN SEALED PACKAGE PRIOR TO CONNECTION WITH NO OBVIOUS ABNORMALITIES. POST FLUSH AND CLAMPING OF SALINE LOCK, THERE WAS A GRAY PARTICULATE MATTER THAT APPEARED INTERNALLY WITHIN THE SALINE LOCK TUBING. SITE WAS ASSESSED BY ANOTHER RN AND THE SALINE LOCK WAS PROMPTLY REMOVED AND REPLACED WITH NEW SALINE LOCK, ASPIRATED, AND FLUSHED WITH 10 ML NS WITHOUT INCIDENT.