MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for PEGASUS PNK 20GA X 1.16IN PRN 383941 manufactured by Bd Rapis Diagnostics (suzhou) Co. Ltd..
[141367873]
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
[141367874]
It was reported that the pegasus pnk 20ga x 1. 16in prn experienced leakage during use. The following information was provided by the customer: event date: (b)(6) 2019. The extension tubing was broken when unclamped before injection. The blood splashed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2019-00258 |
| MDR Report Key | 8492112 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-03-21 |
| Device Manufacturer Date | 2017-04-19 |
| Date Added to Maude | 2019-04-08 |
| 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 | 8015652341 |
| Manufacturer G1 | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Manufacturer Street | 9 RUI PU ROAD EXPORT ZONE B |
| Manufacturer City | SUZHOU |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PEGASUS PNK 20GA X 1.16IN PRN |
| Generic Name | IV CATHETER |
| Product Code | LJS |
| Date Received | 2019-04-08 |
| Catalog Number | 383941 |
| Lot Number | 7109284 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Manufacturer Address | 9 RUI PU ROAD EXPORT ZONE B SUZHOU US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-08 |