MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-19 for NORMAL SALINE POSIFLOW FLUSH, HEPARIN 100U/ML POSIFLOW FLUSH manufactured by Becton Dickinson And Company.
[111851775]
I am currently on tpn, have been stable for the past 8 years and am also a registered nurse. While using the bd brand normal saline/heparin posiflow flushes, i became critically ill. It was determined that i was septic with the bacteria s. Marcescens. This episode of sepsis led to septic shock that required multiple days in the intensive care unit. This is third time i have been septic since (b)(6) despite my central venous catheter being replaced. Testing of my catheter upon removal was negative for bacteria and cultures after each treatment were negative. Upon further research, i became aware that there had been a problem with the same bacteria related to the very flushes i used on a regular basis. None of the flushes i currently have on hand are within the recalled lots which concerns me that the recall hasn't been expanded enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077939 |
| MDR Report Key | 7619036 |
| Date Received | 2018-06-19 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-06-04 |
| Date Added to Maude | 2018-06-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | NORMAL SALINE POSIFLOW FLUSH, HEPARIN 100U/ML POSIFLOW FLUSH |
| Generic Name | HEPARIN, VASCULAR, ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2018-06-19 |
| Lot Number | 729690N |
| Device Expiration Date | 2019-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Brand Name | NORMAL SALINE POSIFLOW FLUSH, HEPARIN 100U/ML POSIFLOW FLUSH |
| Generic Name | HEPARIN, VASCULAR, ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2018-06-19 |
| Lot Number | 802967N |
| Device Expiration Date | 2019-10-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Brand Name | NORMAL SALINE POSIFLOW FLUSH, HEPARIN 100U/ML POSIFLOW FLUSH |
| Generic Name | HEPARIN, VASCULAR, ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2018-06-19 |
| Lot Number | 8017654 |
| Device Expiration Date | 2019-10-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2018-06-19 |