MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2019-02-15 for MINIMED? PRO-SET? BD FLOWSMART? TECHNOLOGY, 24IN X 6MM P-CAP 328614 manufactured by Bd Medical - Diabetes Care.
[137285958]
(b)(6). 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
[137285959]
It was reported that during use of a minimed? Pro-set? Bd flowsmart? Technology, 24in x 6mm p-cap the needle was bent and would not deliver insulin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2019-00163 |
| MDR Report Key | 8344429 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2019-02-15 |
| Date of Report | 2019-04-09 |
| Date of Event | 2017-08-04 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2019-02-15 |
| 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 | BD MEDICAL - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINIMED? PRO-SET? BD FLOWSMART? TECHNOLOGY, 24IN X 6MM P-CAP |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2019-02-15 |
| Catalog Number | 328614 |
| Lot Number | 6207535 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-15 |