MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-03 for BLTPRT PLUS 12MM OBTR + 5MM-12MM SEAL RT 179775P manufactured by Covidien.
[23329383]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23329384]
Procedure: ladg. According to the reporter: during the procedure, this instrument was loaded to a reusable sleeve. When an obturator was inserting into the product, a doctor found that the head part of the obturator had been cracked. Opened another. Opened another. Operating time not extended. Tissue damage: no. Nothing fell into the cavity. No bleeding. No further incident. The patient gender, age, and weight are not provided. The last known patient status: good.
Patient Sequence No: 1, Text Type: D, B5
[26906956]
Evaluation summary:post market vigilance (pmv) led an evaluation of one device sealed. This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, engineering review of the product and an evaluation of the returned device. The product was received with a cracked obturator. The obturator was cracked on two sides of the head. Subsequently, the complaint data did not display an increased trend. Engineering determined the component was improperly assembled causing the crack in the dilator during the manufacturing process. This condition has been brought to the attention of the appropriate manufacturing personnel to ensure the verification of correct product assembly and inspection. A manufacturing enhancement has been initiated to prevent this condition from recurring. There were no adverse patient events reported as a result of the alleged event. Should new information become available, the file will be re-opened and reassessed at that time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612501-2015-00460 |
| MDR Report Key | 4961568 |
| Date Received | 2015-08-03 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-07-22 |
| Date Mfgr Received | 2015-09-15 |
| Date Added to Maude | 2015-08-03 |
| 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 12MM OBTR + 5MM-12MM SEAL RT |
| Generic Name | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDH |
| Date Received | 2015-08-03 |
| Returned To Mfg | 2015-08-25 |
| Model Number | 179775P |
| Catalog Number | 179775P |
| Lot Number | J4J0882X |
| Device Expiration Date | 2019-09-30 |
| 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 | 2015-08-03 |