FDA Adverse Event
Injury
Summary report: N
45 CM 5 FR. D/L GROSHONG NXT UPFT WITH MI AND TLS
MDR report key: 1893209
·
Received October 29, 2010
Report
- Report Number
- 3006260740-2010-00316
- Event Type
- Injury
- Date Received
- October 29, 2010
- Date of Event
- October 23, 2010
- Report Date
- October 27, 2010
- Manufacturer
- C. R. BARD INC., (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K063240
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.
Description of Event or Problem · 1
WHILE FLUSHING THE LINE AFTER PICC WAS INSERTED, PATIENT BEGAN HAVING SHORTNESS OF BREATH, FLUSHING AND REDNESS, DIAPHORESIS, AND NAUSEA. REACTION RESOLVED AFTER 8 MINUTES AND THE PICC WAS LEFT IN THE PT. REPORTING RN WAS NOT THE ONE WHO PLACED THE LINE, AND SHE DOES NOT KNOW IF THE WIRE HAD BEEN PULLED BEFORE FLUSHING, BUT IT IS THE GENERAL PRACTICE TO LEAVE IT IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 45 CM 5 FR. D/L GROSHONG NXT UPFT WITH MI AND TLS | LJS | C. R. BARD INC., (BASD) | REUH0758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |