MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for LIFESHIELD manufactured by Hospira, Inc..
[68371730]
Patient Sequence No: 1, Text Type: N, H10
[68371731]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6360201 |
| MDR Report Key | 6360201 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-02-06 |
| Report Date | 2017-02-06 |
| Date Reported to FDA | 2017-02-06 |
| Date Reported to Mfgr | 2017-02-06 |
| Date Added to Maude | 2017-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESHIELD |
| Generic Name | IV TUBING EXTENSION |
| Product Code | FPK |
| Date Received | 2017-02-27 |
| Lot Number | 66132NS |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA, INC. |
| Manufacturer Address | HIGHWAY 301 NORTH ROCKY MOUNT NC 27801 US 27801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |