MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2014-12-17 for BLTPRT PLUS 5MM-12MM TRC W/BLTGRP 179075P manufactured by Covidien.
[15345155]
Procedure: tap transabdominal preperitoneal. According to the reporter: at preparation for procedure a nurse confirmed a crack in the inner obturator. New one was opened to complete the case with no problem. The defective one was not used on the patient.
Patient Sequence No: 1, Text Type: D, B5
[15644348]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[22999255]
Based on review of the file, this report was updated from a malfunction to a non-reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2014-00456 |
| MDR Report Key | 4338367 |
| Report Source | 06,USER FACILITY |
| Date Received | 2014-12-17 |
| Date of Report | 2014-12-05 |
| Date of Event | 2014-12-04 |
| Date Mfgr Received | 2014-12-05 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-12-31 |
| 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 | 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 | 2014-12-17 |
| Returned To Mfg | 2015-03-20 |
| Model Number | 179075P |
| Catalog Number | 179075P |
| Lot Number | J3D0377X |
| Device Expiration Date | 2018-04-30 |
| 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 | 2014-12-17 |