MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-03-03 for BD POSIFLUSH? XS PRE-FILLED FLUSH SYRINGE NACL 0.9% 306572 manufactured by Becton, Dickinson And Co..
[184157805]
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9248167, medical device expiration date: 2022-08-31, device manufacture date: 2019-09-05. Medical device lot #: 9224747, medical device expiration date: 2022-07-31, device manufacture date: 2019-08-12. 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
[184157806]
It was reported that the patient was admitted to the hospital due to "oxygen levels of 30% on removing bi-pap machine" and "blue swollen lips" when the bd posiflush? Xs pre-filled flush syringe nacl 0. 9% was used to perform a flush on them. "taurolock 3ml amps" was also used on the patient. Lot#'s 9248167 and 9224747 were reported to have been involved in this event, but it is unknown how many occurrences happened within each. The following information was provided by the initial reporter: "patient admitted to hospital on (b)(6) 2020; due to oxygen levels of 30% on removing bi-pap machine with blue swollen lips. Potential for allergic reaction to the saline (flushes and saline bag) and taurolock 3ml amps; the products have been taken to the hospital for testing. No confirmation on cause of allergic reaction yet. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616657-2020-00037 |
| MDR Report Key | 9780384 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD POSIFLUSH? XS PRE-FILLED FLUSH SYRINGE NACL 0.9% |
| Generic Name | SALINE VASCULAR ACCESS FLUSH |
| Product Code | NGT |
| Date Received | 2020-03-03 |
| Catalog Number | 306572 |
| Lot Number | SEE SECTION H.10. |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND CO. |
| Manufacturer Address | DONORE ROAD DROGHEDA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |