MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-03 for PERIPHERALLY INSERTED CENTRAL CATHETER UNK manufactured by Bard Access Systems.
[5143481]
It was reported to the rep that the nurse experienced a scalpel cut with a spectra safe-cut safely scalpel, this occurred a few months ago and the rep has just received the info. The nurse required going to occupational hlth and has since had the all clear from testing. Date: (b)(6) 2014 - attended occupational hlth, bloods obtained from the nurse and the pt, (b)(6) vaccine administered, with booster follow up 2 months and 9 months first aid only required.
Patient Sequence No: 1, Text Type: D, B5
[12705269]
A lot history review (lhr) review is not possible, as no mfg lot number has been provided by the complainant. The device has not been returned to the mfr for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006260740-2014-00586 |
| MDR Report Key | 4332272 |
| Report Source | 05 |
| Date Received | 2014-12-03 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2014-11-20 |
| Date Added to Maude | 2014-12-17 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CHANDONIA |
| Manufacturer Street | 605 NORTH 5600 WEST |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015224969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIPHERALLY INSERTED CENTRAL CATHETER |
| Generic Name | SPECTRA SAFE-CUT - SAFETY SCALPEL |
| Product Code | GDZ |
| Date Received | 2014-12-03 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-03 |