MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-05-16 for BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGES 306424 manufactured by Bd Medical (bd West) Medical Surgical.
[108456436]
This mdr is intended to report 1 of the 2 events described in the event. Another mdr will be filed for the 2nd incident. (2nd event submitted with mdr report# 1911916-2018-00230) the customer's address is unknown. Unknown, (b)(6), 0000 usa has been used as a default. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[108456437]
?it was reported that on two occasions ((b)(6)), after 30 minutes of pushing iv saline, patient experienced a severe reaction (coughing, couldn't breathe, cold sweats) . patient also used heparin flush but thinks the issue was from the saline more so than the heparin . patient went to the er on both occasions and was told that nothing was able to be determined . er checked the patient's lungs, checked for embolism, etc .? there was no additional specific information on the medical interventions received .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00229 |
| MDR Report Key | 7519613 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-05-16 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2017-06-09 |
| Date Added to Maude | 2018-05-16 |
| 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 | PATIENT |
| 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 | 8015652845 |
| Manufacturer G1 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGES |
| Generic Name | HEPARIN FLUSH |
| Product Code | NZW |
| Date Received | 2018-05-16 |
| Catalog Number | 306424 |
| Lot Number | 716087N |
| Device Expiration Date | 2019-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-16 |