MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-11-19 for SURGICAL SUCKER/ SUMP SET 201135N manufactured by Novosci Corp..
[21833235]
On (b)(6) 2014, an incident was reported to novosci by the distributor medtronic. From their reports, during an operation the tip of a tmp sucker came unattached during use in a surgery. It was uncertain if it was broken while in patients chest. The product was discarded and not available for return. The perfusionist stated that there was no injury to patient due to the incident.
Patient Sequence No: 1, Text Type: D, B5
[21851701]
Device was discarded after surgery. We are waiting on additional info from user. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625519-2014-00002 |
| MDR Report Key | 4392401 |
| Report Source | 08 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-11-05 |
| Date Mfgr Received | 2014-11-14 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-01-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2021 AIRPORT RD |
| Manufacturer City | CONROE TX 77301 |
| Manufacturer Country | US |
| Manufacturer Postal | 77301 |
| Manufacturer Phone | 2812103363 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL SUCKER/ SUMP SET |
| Generic Name | ADULT HEX HANDLE GROOVED - TIP SUCKE |
| Product Code | DTS |
| Date Received | 2014-11-19 |
| Model Number | 201135N |
| Lot Number | 295004/ 294810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVOSCI CORP. |
| Manufacturer Address | CONROE TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-19 |