MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for HEPARIN LOCK FLUSH SYRINGES 306516 manufactured by Bd Medical / Becton Dickinson And Company.
[111043846]
After she used heparin lock flush on (b)(6) 2018, she got symptoms like diarrhea, constipation and nausea but on (b)(6) 2018 the symptoms increased. The dr attended sent her to (b)(6) emergency, they said she had blood infections and they gave her antibiotics. Later they said her situation was unusual, her urine analysis contained bacteria. She died as a result of using heparin lock flush. It contained bacteria. The mfr company recalls this medication for this reason. Strength: 500usp units / 5ml (100usp/ml millilitre(s)). "did the problem stop after the person reduced the dose or stopped taking or using the product: no. " quantity: 30 injections, frequency: twice a day. Date the person first started taking or using the product: (b)(6) 2018, date the person stopped taking or using the product: (b)(6) 2018; for line care daily flush each lumen daily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077796 |
| MDR Report Key | 7596044 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-03-06 |
| Date Added to Maude | 2018-06-13 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | HEPARIN LOCK FLUSH SYRINGES |
| Generic Name | HEPARIN LOCK FLUSH SYRINGES |
| Product Code | NZW |
| Date Received | 2018-06-12 |
| Catalog Number | 306516 |
| Lot Number | 726111N |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL / BECTON DICKINSON AND COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-06-12 |