MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-07-07 for BLTPRT PLUS 5MM-12MM TRC W/BLTGRP 179075P manufactured by Covidien.
[4737481]
Procedure type: colorectal; according to the reporter: inserted port as normal and inserted scope. Then noticed a small piece/sliver of plastic had come away from the spring grip and was in the patient. The strip of plastic was removed and the port removed and replaced with another bluntport. It's unknown whether the strip retrieved was retrieved in its entirety. Under visualisation, nothing appeared to be left. The patient is fine. No delay in surgery. No unanticipated blood loss. No tissue damage.
Patient Sequence No: 1, Text Type: D, B5
[12330362]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[12449179]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00215 |
| MDR Report Key | 4063184 |
| Report Source | 01,05 |
| Date Received | 2014-07-07 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-06-19 |
| Date Mfgr Received | 2014-06-19 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-09-11 |
| 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, QA |
| 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 KM17 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | KM17 |
| Single Use | 0 |
| 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 | 2014-07-07 |
| Returned To Mfg | 2014-07-11 |
| Catalog Number | 179075P |
| Lot Number | J3M1054X |
| Device Expiration Date | 2018-12-31 |
| 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 SANTO DOMINGO DO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-07 |