MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-30 for BD PEGASUS? SAFETY CLOSED IV CATHETER SYSTEM 383912 manufactured by Bd (suzhou).
[187102585]
Initial reporter phone #: unknown. 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
[187102586]
It was reported that during use there were burrs on needle which damaged blood vessels and caused extravasation of the drug with a bd pegasus? Safety closed iv catheter system. The following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to the hospital for treatment due to abdominal pain. During the puncturing on (b)(6) 2020 after the operation, it was found that there were burrs on the needle, which damaged the blood vessels and caused the extravasation of the drug solution. The operation was completed after the replacement of the new product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2020-00105 |
| MDR Report Key | 9900900 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-04-16 |
| Date Added to Maude | 2020-03-30 |
| 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 (SUZHOU) |
| Manufacturer Street | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PEGASUS? SAFETY CLOSED IV CATHETER SYSTEM |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | FOZ |
| Date Received | 2020-03-30 |
| Catalog Number | 383912 |
| Lot Number | 9106501 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (SUZHOU) |
| Manufacturer Address | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK SUZHOU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |