MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-23 for BD? R 87 V INFUSION SET 396373 manufactured by Becton Dickinson.
[118239591]
The manufacturing location for this product is (b)(4). This site is not registered with the fda. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1007785, expiration date: 2021-02-01, manufacture date: 2018-03-03. Medical device lot #: 1007786, expiration date: 2021-02-01, manufacture date: 2018-03-06. Initial reporter phone#: (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[118239592]
It was reported that bd? R 87 v infusion set leaked from underneath the dripping chamber. No serious injury or medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-01137 |
| MDR Report Key | 7809711 |
| Date Received | 2018-08-23 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-23 |
| 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 |
| 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 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD? R 87 V INFUSION SET |
| Generic Name | INFUSION SET |
| Product Code | FPK |
| Date Received | 2018-08-23 |
| Catalog Number | 396373 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-23 |