MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for BD POSIFLUSH HEPARIN manufactured by Becton Dickinson And Company.
[112565268]
Pt had four consecutive weeks of becoming ill with diarrhea, nausea and upset stomach within 2 hrs of his weekly ivig on (b)(6) and (b)(6) 2018. Once i looked back on the calendar and my notes, i saw it started on (b)(6). The stomach symptoms, along with lack of appetite, and persistent diarrhea lasted from 2 hrs post each above infusion, until the following tuesday each week. He would then start to feel better and have no symptoms until the next sunday infusion again. This week, using the newly supplied heparin flushes during infusion was the first week without stomach or diarrhea issues, post infusion. We feel it is clear that there was a correlation between the two. Per the recall letter you sent on may 15, we did have both heparin and saline syringes affected in the lots and catalog numbers on the recall sheet. Our nurse kate does not separate shipments by week, but rather empties the new supplies into a larger bag of any overflow supplies every other week, therefore, any older syringes are mixed with the newer ones. I previously discarded the heparin flushes when we spoke last week and am discarding the balance of the saline syringes (other than the harder packaged ref#'s of (b)(4)) today.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078075 |
| MDR Report Key | 7641072 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-04-22 |
| Date Added to Maude | 2018-06-27 |
| 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 | PHARMACIST |
| 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 | BD POSIFLUSH HEPARIN |
| Generic Name | HEPARIN, VASCULAR ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2018-06-26 |
| Returned To Mfg | 2018-04-25 |
| Device Expiration Date | 2018-12-04 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Manufacturer Address | COLUMBUS NE US |
| Brand Name | BD POSIFLUSH HEPARIN |
| Generic Name | HEPARIN, VASCULAR ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2018-06-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Brand Name | NS FLUSH 306500 |
| Generic Name | SALINE, VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2018-06-26 |
| 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. Other | 2018-06-26 |