MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for BD PUREHUB? DISINFECTING CAP 306596 manufactured by Bd Medical (bd West) Medical Surgical.
[129455885]
Date of event: unknown. The date received by manufacturer has been used for this field. 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
[129455886]
It was reported that during use of the bd purehub? Disinfecting cap that sponge separated from cap and stayed stuck to the hub. It was also reported that there was ecessive alcohol in sponge that dripped down patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00757 |
| MDR Report Key | 8134046 |
| Date Received | 2018-12-05 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2018-12-05 |
| 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 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD PUREHUB? DISINFECTING CAP |
| Generic Name | PUREHUB DISINFECTING CAP SINGLE |
| Product Code | LKB |
| Date Received | 2018-12-05 |
| Catalog Number | 306596 |
| Lot Number | 8130613 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-05 |