MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-20 for SCHUHKNECHT SUC. TUBE 24GA 166/355/024 manufactured by Erchinger Medtechnology Gmbh & Co.kg.
[65782701]
The suction tubes have not been returned completely. The front thin tube is missing, which has broken off. We have examined the suction tubes with the following result: the inner tube is broken before the soldering point on the front thin tube of the inner tube. The tube is not broken at the solder joint itself. The inner tube is bent so that the product has been leveraged. This is obvious, so that only the inner tube has bent. The outer tube is undamaged. The production documents (dhr) are available in full: drawing number: (b)(4) rev. A. Inspection plan (b)(4) dated from june 24, 2015. Route card (b)(4) dated from april 09, 2015 with part list. The examination of the production documents showed the correct production of the products.
Patient Sequence No: 1, Text Type: N, H10
[65782702]
Customer initially reports schuhknecht suction tube 24ga broke at hub during use in surgery. (b)(6) 2016 customer reports device broke while suctioning the nasal cavity. No harm done, no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807421-2016-00001 |
| MDR Report Key | 6266061 |
| Date Received | 2017-01-20 |
| Date Mfgr Received | 2016-09-21 |
| Date Added to Maude | 2017-01-20 |
| 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 | TIMO RACK |
| Manufacturer Street | RUDOLF-DIESEL-STRASSE 20 |
| Manufacturer City | TUTTLINGEN, BADEN-W 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 461966250 |
| Manufacturer G1 | ERCHINGER MEDTECHNOLOGY GMBH & CO.KG |
| Manufacturer Street | RUDOLF-DIESEL-STRASSE 20 |
| Manufacturer City | TUTTLINGEN, BADEN-W 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCHUHKNECHT SUC. TUBE 24GA |
| Generic Name | JARIT |
| Product Code | JZF |
| Date Received | 2017-01-20 |
| Returned To Mfg | 2016-09-15 |
| Model Number | 166/355/024 |
| Catalog Number | 166/355/024 |
| Lot Number | 20510506 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERCHINGER MEDTECHNOLOGY GMBH & CO.KG |
| Manufacturer Address | RUDOLF-DIESEL-STRASSE 20 TUTTLINGEN 78532 US 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-20 |