MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-03-27 for BLTPRT PLUS 5MM-12MM TRC W/BLTGRP 179075P manufactured by Covidien.
[5577948]
According to the reporter: prior to opening package, they found obturator broken. Used another device. No patient involved.
Patient Sequence No: 1, Text Type: D, B5
[13057345]
(b)(4). Initial report sent to fda on 03/27/2015.
Patient Sequence No: 1, Text Type: N, H10
[22176730]
Based on review of the file, this incident was determined to be a non-reportable event due to the fact that the product was found damaged in the packaging.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2015-00174 |
| MDR Report Key | 4637311 |
| Report Source | 01,06 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-25 |
| Date of Event | 2015-03-20 |
| Date Mfgr Received | 2015-03-25 |
| Device Manufacturer Date | 2014-10-20 |
| Date Added to Maude | 2015-04-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLTPRT PLUS 5MM-12MM TRC W/BLTGRP |
| Generic Name | DISPOSABLE SURGICAL ACCESS DEVICE |
| Product Code | GDH |
| Date Received | 2015-03-27 |
| Returned To Mfg | 2015-04-20 |
| Model Number | 179075P |
| Catalog Number | 179075P |
| Lot Number | J4K1065X |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-27 |