MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2013-03-06 for SUCTION 3724217 HOUSE IRRIGATOR 2X2.5FR manufactured by Medtronic Xomed Inc..
[3172521]
It was reported that the facility received the instrument set from the or to the decontamination room. A tech found schuknecht suction (b)(4) broken in pan. Instruments then hand washed/irrigated, sent through washer. In prep and pack area, the tech picked up house irrigator (b)(4) and the connection tip fell off.
Patient Sequence No: 1, Text Type: D, B5
[10548832]
(b)(4). Instruments not returned for analysis, no investigative report available. Method: no testing methods performed. As reported: the damage to the instruments was discovered postoperatively, there was no patient impact.
Patient Sequence No: 1, Text Type: N, H10
[102466724]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00198 |
| MDR Report Key | 2991206 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2013-03-06 |
| Date of Report | 2013-02-12 |
| Date of Event | 2013-02-08 |
| Date Mfgr Received | 2013-02-12 |
| Date Added to Maude | 2013-05-13 |
| 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 | MICHELLE ALFORD |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042798197 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUCTION 3724217 HOUSE IRRIGATOR 2X2.5FR |
| Generic Name | TUBE, EAR SUCTION |
| Product Code | JZF |
| Date Received | 2013-03-06 |
| Model Number | 3724217 |
| Catalog Number | 3724217 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE JACKSONVILLE 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-06 |