MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for BD PERISAFE? CATHETER CONNECTOR 400835 manufactured by Carefusion, Inc.
[132575234]
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
[132575235]
It was reported that bd perisafe? Catheter connectors experienced multiple issues including 100 cases of defective connector/adaptor, 100 cases of leakage, 100 cases of damaged packaging, 100 cases of poor seal integrity causing sterility concerns, 100 cases of sterility questioned, and 100 cases of difficulty opening packaging. No lot numbers were provided in association with these incidents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2018-00070 |
| MDR Report Key | 8227486 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2018-12-19 |
| Date Added to Maude | 2019-01-08 |
| 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 |
| 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 | 8015652845 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD PERISAFE? CATHETER CONNECTOR |
| Generic Name | CATHETER CONNECTOR |
| Product Code | GCD |
| Date Received | 2019-01-08 |
| Catalog Number | 400835 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-08 |