MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for BD POSIFLUSH? XS PRE-FILLED FLUSH SYRINGE NACL 0.9% 306572 manufactured by Becton, Dickinson And Co..
[138644056]
Date of event: unknown. The date received by manufacturer has been used for this field. (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
[138644057]
It was reported that bd posiflush? Xs pre-filled flush syringe nacl 0. 9% a patient had a lot of pain when the flush was inserted. Batch is unknown but likely to be 8270683 as we have supplied just this lot on multiple deliveries in 2019. It was stated: "on speaking to the nurse she reports that the patient had reported a lot of pain around her chest and clavicle area non the saline flush been given. The nurse has stopped the flush and the pain has stopped slightly but continues to sting and feel as if something is spreading under the skin, they attempted another 1ml but this occurred again and they have stopped. There is no redness or swelling to the site at present and the patient denies any shortness of breath or chest pain but confirms she has a high heart rate, she is able to feel this in her temple and has done for a few days on and off, and feels generally unwell. I have advised the nurse to clamp the line using the blue clamps as close to the exit site as possible as there may be an internal line fracture and have advised nothing further is put through the line and the patient attends hospital this evening for assessment. The nurse has reiterated this to the patient but as she has a lot going on at home at present and an appointment with her gastro nutrition team at (b)(6) hospital tomorrow she has declined and confirmed she will attend in the morning instead. The patient has full mental capacity and is able to relay the information back with an understanding of the potential dangers of not attending this evening. I have advised that should she develop any further symptoms such as chest pain, shortness of breathe, neck pain, further rapid pule rate or dry cough the patient attends hospital via 999 immediately this evening, she has agreed to this and is happy to do so should any of these symptoms occur. I have spoken to the medical registrar at (b)(6) infirmary in the absence of a gastro registrar been on call, who has taken the details and will log them for the nutrition and gastro team to be aware of for the patients visit tomorrow but has also agreed with my advice that she should ideally attend this evening to be assessed. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616657-2019-00142 |
| MDR Report Key | 8414387 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-02-21 |
| Device Manufacturer Date | 2018-09-27 |
| Date Added to Maude | 2019-03-12 |
| 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 NACL 0.9% |
| Generic Name | SALINE FLUSH |
| Product Code | NZW |
| Date Received | 2019-03-12 |
| Catalog Number | 306572 |
| Lot Number | 8270683 |
| Device Availability | * |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-12 |