MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-11-19 for SURGICAL SUCKER/ SUMP SET 201135NS manufactured by Novosci Corp..
[15904176]
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 the use in a surgery. It was uncertain if the device was broken while in the patients chest. The product was partially saved and pictures were taken for investigation purposes. The perfusionist stated that there was no injury to patient due to the incident. A investigation will follow.
Patient Sequence No: 1, Text Type: D, B5
[16062852]
Pictures of the device were sent. Only partial piece of sucker in pictures. Initial investigation shows that the bonding agent seemed to have worked properly. The failure point for the device was the tip/sucker connection. This is a natural flex point for this device. Based on the pictures the failure seems to be the result of too much force being applied to the tip of sucker causing a break. A direction for use is included for the sucker/sump sets. It directs that care should be used when applying force to the sucker. Any excessive force or improper use could cause the tip to break. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625519-2014-00001 |
| MDR Report Key | 4392400 |
| Report Source | 99 |
| 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 | 201135NS |
| Lot Number | 295044/294810 |
| 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 |