MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for BD POSIFLUSH? XS PRE-FILLED FLUSH SYRINGE 306572 manufactured by Becton, Dickinson And Co..
[139417885]
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8242797. Medical device expiration date: 2021-08-31. Device manufacture date: 2018-08-30. Medical device lot #: 8270683. Medical device expiration date: 2021-08-31. Device manufacture date: 2018-09-27. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[139417886]
It was reported that after using bd posiflush? Xs pre-filled flush syringe, patient experienced symptoms of nausea, slight increase in body temperature. There was unknown cause of pyrexia. Patient was advice to go to hospital. Customer? S verbatim:? We have received an adverse event report on (b)(6) 2019 concerning the aforementioned product, whereby patient experienced symptoms of nausea and slight increase in body temperature - no known cause for pyrexia. Patient advised to attend hospital; no further information has been obtained in regards to patient outcome following a& e visit. Product - 306572 pfs 0. 9% p/flush xs saline. Batch - 8242797 / 8270683. Samples: no use: 10 ml to flush line before and 20 ml after each infusion as directed.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616657-2019-00155 |
| MDR Report Key | 8436697 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-03-04 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON AND CO. |
| Manufacturer Street | DONORE ROAD |
| Manufacturer City | DROGHEDA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD POSIFLUSH? XS PRE-FILLED FLUSH SYRINGE |
| Generic Name | SALINE FLUSH |
| Product Code | NGT |
| Date Received | 2019-03-20 |
| Catalog Number | 306572 |
| Lot Number | SEE H.10. |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND CO. |
| Manufacturer Address | DONORE ROAD DROGHEDA US |
| Brand Name | BD POSIFLUSH? XS PRE-FILLED FLUSH SYRINGE |
| Generic Name | SALINE FLUSH |
| Product Code | NZW |
| Date Received | 2019-03-20 |
| Catalog Number | 306572 |
| Lot Number | SEE H.10. |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND CO. |
| Manufacturer Address | DONORE ROAD DROGHEDA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-20 |